Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| B. Braun | Lactated Ringer’s Injection, E7500, 1L | Drugs | Products were found to contain particulate matter in solution | B. Braun Medical Inc. | … and pediatric patients as a source of electrolytes and water for hydration. Lactated Ringer's Injection USP is supplied sterile and nonpyrogenic in plastic containers packaged 12 … | ||
| B Braun | 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers | Drugs | Potential for particulate matter and fluid leakage of the containers | B. Braun Medical Inc. | … organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of … and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride for Injection USP … | ||
| Hikma | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL | Drugs | Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). | Hikma Pharmaceuticals PLC | … was manufactured on 3/19/2024. Acetaminophen Injection is a sterile, nonpyrogenic ready-to-use solution, available in IV … citric acid, USP, sodium chloride, USP (tonicity agent) and water for injection. pH may be adjusted with hydrochloric … | ||
| Medline and Centurion | Convenience kits | Medical Devices | The potential for a lack of sterility | Medline Industries, LP | … recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a … Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP. The Nurse Assist recall … | ||
| Fendall 2000 | Non-Sterile Eyewash Cartridge | Drugs | Non-compliance with current good manufacturing practice (cGMP) requirements. | Honeywell Safety Products USA | … USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash … level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant … products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium … | ||
| Par Pharmaceutical | Treprostinil 20mg/20mL Injection | Drugs | Potential Presence of Silicone Particulate Matter | Endo International, Par Pharmaceutical | … (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under … | ||
| Avanos Medical | MIC* Gastric-Jejunal Feeding Tube Kits | Medical Devices | Potential Lack of Sterility Assurance | Avanos Medical, Inc. | … LLC voluntary recall of pre-filled syringes and other sterile water products, Avanos Medical, Inc. (NYSE: AVNS) … include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon … | ||
| Covidien and Cardinal Health | Expanded list of Urology and OR room specific kits and trays | Medical Devices | Potential lack of sterility assurance which could result in non-sterile product | Cardinal Health | … 2302419564 2311517164 10142 2324809764 SAF VAC 14FR 2 L GL WATER TRAY 10102 2226313264 SAF VAC 10FR 2L GL WATER TRAY … trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. … for a lack of sterility assurance which could result in non-sterile product. In populations most at risk, such as … | ||
| Aligned Medical Solutions | Convenience kits containing saline | Medical Devices | Product cannot be verified as having the required sterility assurance level | Aligned Medical Solutions | … Billings, MT, initiated a nationwide recall of Nurse Assist Sterile Saline which is piggybacked [attached to the outside … Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Recalled products … Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation … | ||
| Atrium | Express Drains | Medical Devices | Syringes provided with Express Drains could not be verified to be sterile. | Getinge/Atrium Medical Corporation | … Getinge received notice from Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being recalled because they could not be verified to be sterile. Pre-packaged with every Express chest drain, the … |