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  1. Medical Device Supply Chain and Shortages

Medical Device Shortages List

Update: July 10, 2024

The FDA updated this web page by adding the following product code to the shortages list:

  • MDB (System, Blood Culturing) 

The FDA updated this web page by removing the following product codes from the shortages list:

  • MKJ (Automated External Defibrillators)
  • MVK (Automated External Defibrillators)

The FDA updated this web page by adding the following product codes to the discontinuance list:

  • MKJ (Automated External Defibrillators)
  • FRN (Pump, Infusion)
  • GEI (Electrosurgical, Cutting & Coagulation & Accessories)
  • HEX (Colposcope (And Colpomicroscope))
  • HIB (Speculum, Vaginal, Nonmetal)
  • HDF (Speculum, Vaginal, Metal)

The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices determined to be in shortage. The medical device shortages list reflects the categories of devices the FDA has determined to be in shortage. The presence of a device type on this list does not necessarily indicate that patient care has been affected. In addition, the FDA provides a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.

The Office of Supply Chain Resilience is responsible for managing CDRH's activities to anticipate and prevent disruptions to the supply chain for medical devices, including managing the medical device shortage list.

On this page:

Related pages:


Device Shortage List

Categories of devices that are currently on the device shortage list1 are:

Category Product Code (Description) Availability and Estimated Shortage Duration Additional Information Reason for Interruption (per 506J) Date (YYYY/MM/DD)
Cardiovascular - Circulatory Support, Structural and Vascular Devices DSP (Intra-aortic Balloon and Control System)
  • Estimated through winter 2024.
To provide recommendations to health care providers and facilities who use these devices, the FDA is providing IABP Shortage - Letter to Health Care Providers
  • Demand increase for the device
  • Shortage or discontinuance of a component, part or accessory of the device

2022/12/02 Initial

2024/04/26 Reverified
Cardiovascular - Circulatory Support, Structural and Vascular Devices BYS (Oxygenator, Long Term Support Greater Than 6 Hours)
  • Estimated through summer of 2024.
Oxygenator devices intended for extracorporeal circulation are in shortage.
  • Shortage or discontinuance of a component, part or accessory of the device. 
2023/09/11 Initial
Cardiovascular - Circulatory Support, Structural and Vascular Devices DTZ (Oxygenator, Cardiopulmonary Bypass)
  • Estimated through summer of 2024.
Oxygenator devices intended for extracorporeal circulation are in shortage.
  • Shortage or discontinuance of a component, part or accessory of the device. 
2023/09/11 Initial
Microbiology - Microbiology Devices MDB (System, Blood Culturing) 
  • Estimated through Q4 2024
To provide recommendations to health care providers and laboratories that use blood culture media bottles intended for bloodstream infection testing, the FDA is providing a MDB Shortage - Letter to Health Care Providers.
 
  • Shortage or discontinuance of a component, part or accessory of the device.
2024/07/10 Initial

1. The FDA is still compiling and evaluating data on manufacturing and production capacity and will update the list when more data are available.

Discontinuance List

As part of the list required to be established and maintained pursuant to section 506J(g) of the FD&C Act, the FDA is providing a separate, publicly available, up-to-date list of the devices that the FDA has been informed by the applicable manufacturer have been permanently discontinued. The FDA will update this list when it receives additional information regarding device discontinuances.

Categories of devices in the discontinuance list are:

  • Anesthesiology
  • Cardiovascular
  • Clinical Chemistry
  • Gastroenterology/Urology
  • General & Plastic Surgery
  • General Hospital
  • Microbiology
  • Obstetrics/Gynecology
  • Orthopedic
  • Radiology

Category

Product Code

Manufacturer Name

Device Trade Name

Reason for Discontinuance

Date Posted (YYYY/MM/DD)

General Hospital – Drug Delivery and General Hospital Devices, and Human Factors Devices FRN (Pump, Infusion) Fresenius Kabi AG Agilia Infusion Pump (Model: VOLUMAT MC AGILIA US, Product Code: Z021135)

Discontinuance of the manufacture of the device.
Alternatives are available for customers.

 

2024/07/10
General & Plastic Surgery  – General Surgery Devices GEI (Electrosurgical, Cutting & Coagulation & Accessories) Pro Med Instruments GmbH
  • DORO Non-Stick Bipolar Forceps
  • DORO Bipolar Reusable Cables
Discontinuance of the manufacture of the device as of April 23, 2024. 2024/07/10
Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices  HEX (Colposcope (And Colpomicroscope)) DYSIS Medical 
  • DYSIS Classic Digital Colposcope (SKU DYS302)
  • DYSIS Ultra 2.0 Digital Colposcope (SKU DYS403)
  • DYSIS Ultra 3.0 Digital Colposcope (SKU DYS404)
  • DYSIS View Digital Colposcope (SKU VIE001)
Discontinuance of the manufacture of the device 2024/07/10
Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices HDF (Speculum, Vaginal, Metal) DYSIS Medical
  • DYSIS Reusable Speculum-small (SKU RSP001)
  • DYSIS Reusable Speculum-large (SKU RSP003)
  • DYSIS Reusable Speculum -large wide (SKU RSP004)
  • DYSIS Reusable Speculum-large wide offset (SKU RSP005)
  • DYSIS Reusable Speculum-medium narrow (SKU RSP006)
Discontinuance of the manufacture of the device. 2024/07/10
Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices HIB (Speculum, Vaginal, Nonmetal) DYSIS Medical
  • DYSIS Disposable Speculum-small (SKU DSP001)
  • DYSIS Disposable Speculum-medium (SKU DSP002)
  • DYSIS Disposable Speculum-large (SKU DSP003)
  • DYSIS Disposable Treatment Pipe (SKU TRP001)
Discontinuance of the manufacture of the device. 2024/07/10

Anesthesiology - Anesthesia, Respiratory, and Sleep Devices

BSZ (Anesthesia system- Ventilation- Related Product)

GE Healthcare

  • Aestiva MRI

Discontinuance of the manufacture of the device

2022/10/31

Obstetrics/Gynecology - Reproductive, Gynecology, and Urology

MQK (Labware, Assisted Reproduction)

PUD (Labware, Assisted Reproduction, Exempt)

Corning Incorporated

  • Falcon 60 mm TC-treated in vitro Fertilization (IVF) Dish (SKU 353652)
  • Falcon 60 mm TC-treated Center Well in vitro Fertilization (IVF) /Organ Culture Dish (SKU 353653)
  • Falcon 4-well TC-treated in vitro Fertilization (IVF) Plate (SKU 353654)
  • Falcon 50 mm x 9 mm Not TC-treated in vitro Fertilization (IVF)/Low Wall Dish (SKU 353655)
  • Falcon 4-well TC-treated in vitro Fertilization (IVF) Dish (SKU 353671)

Discontinuance of the manufacture of the device

2023/06/08

Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring MKJ
(Automated External Defibrillators)
Philips Medical Systems
  • HeartStart FR3 Defibrillator
  • FR3 Rechargeable Battery
  • FR3 Battery Charger 
Discontinuance of the manufacture of the device 2024/07/10

Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring

MKJ
(Automated External Defibrillators)

Stryker - Physio- Control, Inc.

LIFEPAK 20e defibrillator/ monitor: 

  • 70402-
    • 000001, 000030, 000059, 000100, 000159, 000160, 000161
  • 70507-
    • 000001, 000055, 000061, 000080, 000081, 000091
  • 94507-
    • 000018
  • 97402-
    • 000001, 000002, 000003, 000005, 000006, 000007
  • 99402-
    • 000001, 000016, 000033, 000065, 000066, 000067
  • 99507-
    • 000001, 000002, 000010, 000016, 000092, 000093, 000102, 000106, 000112, 000122, 000132, 000133

Discontinuance of the manufacture of the device, as of January 12, 2023, alternatives are available for customers.

2023/06/08

Clinical Chemistry - Chemistry and Toxicology Devices

NBW (System, Test, Blood Glucose, Over the Counter)

Abbott Diabetes Care Inc.

  • OptiumEZ Blood Glucose Monitoring System, 71065-01

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/10/31

Radiology - Radiological Imaging and Radiation Therapy Devices

ITX (Transducer, Ultrasonic, Diagnostic)

SUPERSONIC IMAGINE

Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000)

Discontinuance of the manufacture of the device.

2024/04/26

Radiology - Radiological Imaging and Radiation Therapy Devices

IYN (System, Imaging, Pulsed Doppler, Ultrasonic)

SUPERSONIC IMAGINE

Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000)

Discontinuance of the manufacture of the device.

2024/04/26

Radiology - Radiological Imaging and Radiation Therapy Devices

IYO (System, Imaging, Pulsed Echo, Ultrasonic)

SUPERSONIC IMAGINE

Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000)

Discontinuance of the manufacture of the device.

2024/04/26

Radiology - Radiological Imaging and Radiation Therapy Devices

LZC (Patient Examination Glove, Specialty)

Cardinal Health

  • Gloves, Exam, Nitrile, Sterile, PRS, PF
    • S, N8830
    • M, N8831
    • L, N8832
    • XL, N8833

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/10/31

General Hospital - Infection Control and Plastic and Reconstructive Surgery

NGT (Saline, Vascular Access Flush)

Cardinal Health

  • Saline Syringe, Sterile
    • 12CC, (10CC), 8881570121
    • 12ML, (3ML), 8881570123
    • 12CC, (5CC), 8881570125

Discontinuance of the manufacture of the device

2022/03/21

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

OAY

KARL STORZ

  • Photodynamic Diagnostic D-Light C (PDD) Flexible System

Discontinuance of the manufacture of the device.

2023/12/18

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

20F PULL Ponsky:

  • Non-Safety Deluxe
  • G Non-Safety
  • Non-Safety Standard

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

Ponsky Non-Balloon Replacement Tube

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

20F PUSH Ponsky

  • Non-Safety Deluxe
  • G Non-Safety
  • Non-Safety Standard

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

Tri-Funnel Gastrostomy tube

  • 12F
  • 14F
  • 16F
  • 18F
  • 20F

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

Jejunal Feeding/ Gastric Decompression tube

  • 9F Pull 20F
  • 9F Push 20F
  • 12F Pull 28F
  • 12F Push 28F

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KNT (Tubes, Gastrointestinal (and accessories))

Bard Access Systems, Inc.

Dual Port Adapter

  • 20F
  • 28F

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KGC (Tube, Gastro-Enterostomy)

Bard Access Systems, Inc.

Button Gastrostomy tube Kit

  • 18F 1.2cm
  • 18F 1.7cm
  • 18F 2.4cm
  • 18F 3.4cm
  • 24F 1.2cm
  • 24F 1.7cm
  • 24F 2.4cm
  • 24F 3.4cm
  • 24F 4.4cm
  • 28F 1.5cm
  • 28F 2.7cm
  • 28F 4.3cm

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KGC (Tube, Gastro-Enterostomy)

Bard Access Systems, Inc.

Continuous Feeding Tube

  • 18F
  • 24F
  • 28F

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KGC (Tube, Gastro-Enterostomy)

Bard Access Systems, Inc.

Bolus Feeding Tube

  • 18F
  • 24F
  • 28F

Discontinuance of the manufacture of the device

2021/05/04

Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices

KGC (Tube, Gastro-Enterostomy)

Bard Access Systems, Inc.

Decompression Tube

  • 18F 1.2cm
  • 18F 1.7cm
  • 18F 2.4cm
  • 18F 3.4cm
  • 24F 1.2cm
  • 24F 1.7cm
  • 24F 2.4cm
  • 24F 3.4cm
  • 24F 4.4cm
  • 28F 1.5cm
  • 28F 2.7cm
  • 28F 4.3cm

Discontinuance of the manufacture of the device

Manufacturer has indicated that these will be offered through 9/30/2022.

2021/05/04

General & Plastic Surgery - General Surgery Devices

GCJ (Laparoscope, General & Plastic Surgery)

Vernacare Ltd.

NUBERT US New Bag for Endoscopic Retrieval of Tissue, 24003US

Discontinuance of the manufacture of the device.

2024/02/19

General & Plastic Surgery - General Surgery Devices

GCJ (Laparoscope, General & Plastic Surgery)

Vernacare Ltd.

NUBERT DS New Bag for Endoscopic Retrieval of Tissue (US only), 24003DS

Discontinuance of the manufacture of the device.

2024/02/19

General & Plastic Surgery - General Surgery Devices

GCJ (Laparoscope, General & Plastic Surgery)

Vernacare Ltd.

NUBERT Plus New Bag for Endoscopic Retrieval of Tissue, 24004

Discontinuance of the manufacture of the device.

2024/02/19

General & Plastic Surgery - General Surgery Devices

GCJ (Laparoscope, General & Plastic Surgery)

Vernacare Ltd.

NUBERT DS Bag for Endoscopic Retrieval of Tissue (draw string bag), 24005

Discontinuance of the manufacture of the device.

2024/02/19

General Hospital - Infection Control and Plastic and Reconstructive Surgery

LZA (Polymer Patient Examination Glove)

Cardinal Health

  • Gloves, Exam, Nitrile, PF
    • S, 88LC02S
    • M, 88LC03M
    • L, 88LC04L

Discontinuance of the manufacture of the device

2022/07/19

General Hospital - Drug Delivery and General Hospital Devices, and Human Factors

FRN (Infusion Pump)

MEA (Infusion Pump, Patient Controlled Analgesic))

Becton Dickinson and Company (CME America, LLC)

BodyGuard Infusion Pump System
BodyGuard Syringe Pump System, BodyGuard microsets

Shortage or discontinuance of a component or part;
Discontinuance of the manufacture of the device;
Facility closure

2020/08/14

Microbiology - Microbiology Devices

JSM (Culture Media, Non-propagating)

Mediatech, Inc.

Viral Transport Media, 3 mL, Product 25-400-CRS

Discontinuance of the manufacture of the device

2022/08/26

Microbiology - Microbiology Devices

QMC (Transport Medium, Notified Per The Vtm Guidance)

Mediatech, Inc.

Corning Viral Transport Media, 3 mL, Product 25-501-CRS

Discontinuance of the manufacture of the device

2022/08/26

Clinical Chemistry - Chemistry and Toxicology Devices

LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use)

Kartell Spa

  • Oxford Type Tips 5:200µl (1000 pcs), 0096600
  • Sterile Filter Tips in Rack Gilson grad. 1 :150µl, 0963600

Discontinuance of the manufacture of the device

2022/07/19

Microbiology - Microbiology Devices

QMC (Transport Medium, Notified Per The Vtm Guidance)

LaunchWorks CDMO

  • LWS-002 or R-VTM (Room Temp - Viral Media Transport)

Discontinuance of the manufacture of the device

2022/07/19

Clinical Chemistry - Chemistry and Toxicology Devices

NSU (Instrumentation for clinical multiplex test system)

BioFire Diagnostics, LLC

FilmArray Instrument (FLM1-ASY-0001)

Discontinuance of the manufacture of the device

2021/01/22

General & Plastic Surgery - General Surgery Devices

GAA (Needle, Aspiration and Injection, Disposable)

Becton, Dickinson & Co.

  • Needle Filter 19X1-1/2 TW, 305200

Discontinuance of the manufacture of the device

2022/07/19

General & Plastic Surgery - General Surgery Devices

GAA (Needle, Aspiration and Injection, Disposable)

Becton, Dickinson & Co.

  • Needle Filter 19X1-1/2 TW, 305200
  • Needle Blunt Fill 20X1
  • Needle Blunt Filter 18X1-1/2 TW

Discontinuance of the manufacture of the device

2022/08/26

Orthopedic - Restorative, Repair and Trauma Devices

MOZ (Acid, Hyaluronic, Intraarticular)

Teva Pharmaceuticals USA, Inc.

Synojoynt (Sodium Hyaluronate 1% INJ 10mg/ml 3X2M)*

Discontinuance of the manufacture of the device

2021/02/26

Anesthesiology - Anesthesia, Respiratory, and Sleep Devices

NFB (Oxygen Conserver)

Inovo, Inc.

Single Lumen Conservers;
Accupulse;
Inovo, Inc. Accupulse Single Lumen Conserving Regulator
Dual Lumen Conservers;
Economizer;
Inovo, Inc. Economizer Conserving Regulator

Discontinuance of the manufacture of the device

2021/02/26

Gastroenterology/Urology - Renal, Gastrointestinal, Obesity and Transplant Devices

FKO (Catheter, Peritoneal Dialysis, Single Use)

Becton Dickinson and Company (CareFusion 2200 Inc.)

Lazarus-Nelson Peritoneal Lavage Tray – LNT9000

Discontinuance of the manufacture of the device

2022/12/02

Clinical Chemistry - Chemistry and Toxicology Devices

JKA (Tubes, vials, systems, serum separators, blood collection)

ITL Asia Pacific Sdn. Bhd.

  • SampLok® Adapter
    • Cap Insert, A100709
    • Cap 2, A100715
    • Cap 2, A100718
    • Cap 3, A100762
    • Cap 3 Insert, A100763

Discontinuance of the manufacture of the device

2022/07/19

General Hospital - Infection Control and Plastic and Reconstructive Surgery

KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)

Becton Dickinson and Company (ContainMed Inc.)

V. Mueller Horseshoe Retraction Kit Blades and Clamps Insert
V. Mueller Horseshoe Retraction Kit Frames and Post Insert
V. Mueller Universal Ring Retraction Set Blades and Rings Insert
V. Mueller Universal Ring Retraction Set and Posts Insert

Discontinuance of the manufacture of the device

2021/02/26

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Mask, Surgical)

CHISON Medical Technologies Co., Ltd.

  • M1, Surgical Face Mask

Discontinuance of the manufacture of the device

2022/07/19

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Mask, Surgical)

Huizhou Foryou Medical Devices Co., Ltd

  • BANGY, Medical Face Masks, 17.5cm X 9.5cm

Discontinuance of the manufacture of the device

2022/07/19

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Mask, Surgical)

Cardinal Health

  • Mask, Procedure
    • Blue, AT71021
    • Yellow, AT7004

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/07/19

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FME (Gown, Examination)

Cardinal Health

Gown Iso Polycoated, Knit Cuff, XL, White, 7301PG

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXP (Cover, Shoe, Operating-Room)

Cardinal Health

  • Shoe Cover
    • Premium, 5850
    • Ankle-top, 8357
    • XL, Ankle-top, 8358A
    • XXL, Anti-skid, 4855
    • Anti-skid, 4875
    • SI, Anti-skid, SMS Sport, 4859SS
    • Universal, Economy Zone, 8451
    • XL, Economy Zone, 8452
    • Universal, Critical Zone, 8453
    • XL, Critical Zone, 8454

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Mask, Surgical)

Cardinal Health

  • Mask, Procedure, Blue, AT71021

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General & Plastic Surgery - General Surgery Devices

FYF (Cap, Surgical)

Cardinal Health

  • Bouffant
    • 24", Green Comfort, 3224G
    • 27", White Comfort, 9304
    • Beard Cover Full Coverage, 9216

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General Hospital - Infection Control and Plastic and Reconstructive Surgery

LYU (Accessory, Surgical Apparel)

Cardinal Health

  • Lab Coat SMS Traditional Collar
    • M, White, 2301LC
    • L, White, 2302LC
    • 2XL, White, 2304LC
  • Jacket Lab DISP Hip Length
    • XS, Ciel Blue, C3630CBXS
    • XS, Medical Blue, C3630MBXS
    • 2XL, Purple, C3630PP2XL
    • 3XL, Purple, C3630PP3XL
    • L, Purple, C3630PPL
    • M, Purple, C3630PPM
    • S, Purple, C3630PPS
    • XL, Purple, C3630PPXL
    • XS, Purple, C3630PPXS
    • 2XL, Raspberry, C3630RB2XL
    • 3XL, Raspberry, C3630RB3XL
    • L, Raspberry, C3630RBL
    • M, Raspberry, C3630RBM
    • XL, Raspberry, C3630RBXL
    • S, Raspberry, C3630RBS
    • XS, Raspberry, C3630RBXS
    • 2XL, Sky Blue, C3630SB2XL
    • 3XL, Sky Blue, C3630SB3XL
    • L, Sky Blue, C3630SBL
    • M, Sky Blue, C3630SBM
    • S, Sky Blue, C3630SBS
    • XL, Sky Blue, C3630SBXL
    • 2XL, Teal, C3630TE2XL
    • 3XL, Teal, C3630TE3XL
    • M, Teal, C3630TEM
    • L, Teal, C3630TEL
    • S, Teal, C3630TES
    • XL, Teal, C3630TEXL
    • XS, White, C3630WHXS
  • Coat Lab Mid Length Element
    • 2XL, Gray, C3650EG2XL
    • 3XL, Gray, C3650EG3XL
    • 4XL, Gray, C3650EG4XL
    • L, Gray, C3650EGL
    • M, Gray, C3650EGM
    • S, Gray, C3650EGS
    • XL, Gray, C3650EGXL
  • Coat Lab DISP Knee Length
    • XS, Medical Blue, C3660MBXS
    • 2XL, Purple, C3660PP2XL
    • 3XL, Purple, C3660PP3XL
    • L, Purple, C3660PPL
    • M, Purple, C3660PPM
    • S, Purple, C3660PPS
    • XL, Purple, C3660PPXL
    • 2XL, Raspberry, C3660RB2XL
    • 3XL, Raspberry, C3660RB3XL
    • L, Raspberry, C3660RBL
    • M, Raspberry, C3660RBM
    • S, Raspberry, C3660RBS
    • XL, Raspberry, C3660RBXL
    • XS, Raspberry, C3660RBXS
    • 3XL, Sky Blue, C3660SB3XL
    • 2XL, Sky Blue, C3660SB2XL
    • L, Sky Blue, C3660SBL
    • M, Sky Blue, C3660SBM
    • S, Sky Blue, C3660SBS
    • XL, Sky Blue, C3660SBXL
    • 2XL, Teal, C3660TE2XL
    • 3XL, Teal, C3660TE3XL
    • L, Teal, C3660TEL
    • M, Teal, C3660TEM
    • S, Teal, C3660TES
    • XL, Teal, C3660TEXL
    • L, White, Traditional, C3660WHLT
    • M, White, Traditional, C3660WHMT
    • S, White, Traditional, C3660WHST
    • XL, White, Traditional, C3660WHXLT
    • XS, White, Traditional, C3660WHXST

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General Hospital - Drug Delivery and General Hospital Devices, and Human Factors

OEA (Non-Surgical Isolation Gown)

 

  • Gown
    • Universal, Isolation, LTWT, W/Ties, Blue, 1200PG
    • Universal, Isolation, W/Hook Loop, Yellow, 2150PG
    • Universal, Isolation, SMS, W/Ties, Blue, 2200PG
    • XL, Isolation, SMS, W/Ties, Blue, 2201PG
    • Universal, Polycoated, Knit Cuff, Blue, 42110PG
    • Universal, Iso AAMI 1, Tape Tab, Yellow, AT2237-BD
    • XL, Iso AAMI 1, Tape Tab, Yellow, AT2237-XL
    • XL, Poly, SNGL, Kool-Gard, AT4441

Discontinuance of the manufacture of the device, alternatives are available for customers

2022/03/21

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Mask, Surgical)

Inno Foods Inc.

Mask, Surgical 3D

Discontinuance of the manufacture of the device

2023/03/16

General Hospital - Infection Control and Plastic and Reconstructive Surgery

FXX (Surgical mask)

3M Company

3M Triple Layer Molded Face Mask (2042F), 3M Triple Layer Molded Face Mask, Petite (2042FP)

Discontinuance of the manufacture of the device

2021/01/22

General & Plastic Surgery - General Surgery Devices

FYF (Cap, Surgical)

Cardinal Health

  • Bouffant
    • 25", White Designer, 3276

Discontinuance of the manufacture of the device, alternatives are available for customers

2023/03/16

General Hospital - Infection Control and Plastic and Reconstructive Surgery

LYU (Accessory, Surgical Apparel)

Inno Foods Inc.

  • Mask, Inno LifeCare Face Mask

Discontinuance of the manufacture of the device

2023/03/16

Anesthesiology - Anesthesia, Respiratory, and Sleep Devices

CAW (Generator, Oxygen, Portable)

Invacare Corporation

  • Platinum 5NXG
  • Perfecto2 V Oxygen Concentrator with SensO2
  • Platinum 10 Concentrator with SensO2
  • HomeFill Compressor
  • HomeFill Ambulatory System (D)
  • HomeFill Ambulatory System (M2)
  • HomeFill Ambulatory System (M9); IOH200PPC9, IOH200PV9
  • HomeFill Ambulatory System (ML4)
  • HomeFill Ambulatory System (ML6); IOH200PPC, IOH200PV6
  • HomeFill Cylinder M2 with Integrated Conserver and Carrying Bag
  • HomeFill Cylinder M9 with Integrated Conserver
  • HomeFill Cylinder ML4 with Integrated Conserver
  • HomeFill Cylinder ML6 with Integrated Conserver
  • Platinum Mobile Portable Concentrator
  • Platinum Mobile Portable Concentrator with extra battery

Discontinuance of the manufacture of the device

2023/03/16

Cardiovascular - Circulatory Support, Structural and Vascular Devices

DSQ (Ventricular (Assist) Bypass)

Abbott Medical

HeartMate II™ Left Ventricular Assist System (Model/ Catalog Number)

  • HeartMate II LVAS EP System Controller 
    • (103696)
  • HeartMate II LVAS Kit 
    • (104911)
  • HeartMate II LVAS Display Module 
    • (1280N)
  • HeartMate II LVAS Display Module (Rental) 
    • (L28305)
  • HeartMate II LVAS Display Module (Service) 
    • (L28305-TS)
  • Shower Bag, HeartMate II LVAS EPC 
    • (104216)
  • Consolidated Bag (Left), HeartMate II LVAS EPC 
    • (104222)
  • Consolidated Bag (Right), HeartMate II LVAS EPC 
    • (104223)
  • Vest, Small, HeartMate II LVAS EPC 
    • (104224)
  • Vest, Medium, HeartMate II LVAS EPC 
    • (104225)
  • Vest, Large, HeartMate II LVAS EPC 
    • (104226)
  • Stabilization Belt, S-M, HeartMate II LVAS EPC 
    • (104227)
  • Stabilization Belt, L, HeartMate II LVAS EPC 
    • (104228)
  • Battery Holster, HeartMate II LVAS EPC
    • (103479)
  • HeartMate Display Module to Power Module Adapter Cable 
    • (103871)
  • EP Controller Battery Module 
    • (1264)
  • HeartMate II LVAS Implant Kit (US) 
    • (106015)
  • HeartMate II System Controller (US) 
    • (106762)
  • HeartMate II Sealed Outflow Graft with Bend Relief 
    • (103393)
  • HeartMate II Sealed Inflow Conduit 
    • (104142)
  • HeartMate II Sealed Standalone Short Bend Relief 
    • (104692)
  • HeartMate II LVAS Mini Implant Kit 
    • (107801)
  • HeartMate II Apical Sewing Ring
    • (1065)
  • HeartMate II Thread Protector 
    • (105558)
  • HeartMate II Skin Coring Punch
    • (105557)
  • HeartMate II Tunneler 
    • (102137)
  • HeartMate II Surgical Sizer 
    • (102772)
  • HeartMate II Sealed Outflow Bend Relief Collar 
    • (107315)
  • HeartMate II Spanner Wrench 
    • (102138)
  • Power Module DC Input Cable 
    • (2230)
  • HeartMate II Stabilization Belt, Small/Medium 
    • (100759)
  • HeartMate II Stabilization Belt, Large/Extra Large 
    • (100760)
  • HeartMate II Outflow Graft with Bend Relief (4 inches) 
    • (102563)
  • HeartMate II Inflow Conduit 
    • (102564)
  • HeartMate II Short Outflow Graft Bend Relief 9 3 inches) 
    • (102781)
  • HeartMate II LVAS Implant Kit (with RSOC Controller) 
    • (103693)
  • HeartMate II Unshielded Patient Cable 
    • (10002010)
  • HeartMate II Patient Support Kit with Power Module 
    • (106101)
  • HeartMate II Patient Support Kit with Automobile DC Power Cable and Power Module Patient Cable 
    • (106102)
  • HeartMate II-Demo Pump Kit-Pkt 
    • (107794)
  • HeartMate II-Pocket Controller, Demo 
    • (107859)
  • HeartMate II-Double Zippered Demo Bag 
    • (108318)
  • HeartMate II-Foam Set, Demo Bag 
    • (108319)
  • Screw Tubing Clamp 
    • (108326)
  • HeartMate II-Mock Loop Tubing Assembly 
    • 108428)
  • HeartMate II, Demo System Controller, Functional, EP 
    • (105253D)
  • HeartMate II, Demo System Controller, Functional, Pocket 
    • (108317D)
  • Packaging & Labeling Perc Cable Repair Kit 
    • (104716)
  • Packaging & Labeling Perc Cable Repair Kit 
    • (10006496)
  • HeartMate II-Training Kit, Pocket 
    • (108327)
  • Return Kit, Pocket Controller 
    • (10001089)

Discontinuance of the manufacture of the device as of December 31, 2026. 
Alternatives are available for customers. 
 

2023/12/18

General Hospital - Drug Delivery and General Hospital Devices, and Human Factors

FLL (Thermometer, Electronic Clinical)

Philips Medizin Systeme Böblingen GmbH

Tympanic Temperature Module

Discontinuance of the manufacture of the device

2021/11/23

Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring Devices

DSJ (Alarm, Blood-Pressure)

Philips Medical Systems

SureSigns VS4 NBP, SPO2
SureSigns VS4 U.S. Gov NBP, SPO2
SureSigns VS4 Government Bundle

Discontinuance of the manufacture of the device

2021/02/26

Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring Devices

MSX (Cardiac monitor, including cardiotachometer and rate alarm)

Philips Medical Systems

IntelliSpace Event Management

Discontinuance of the manufacture of the device

2020/09/24

How the FDA Determines What Devices are in Shortage

For more information, see Supply and Shortages of Medical Devices: Frequently Asked Questions and Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health.

 
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