| August 24, 2026 | Certain NOxBOXi Nitric Oxide Delivery System with the NOxMixer modules | New | FDA reports that NOxBOX has issued a letter to affected customers recommending certain nitric oxide delivery systems have updated use instructions | Medical Devices |
| August 24, 2026 | Specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set | New | FDA reports that CooperSurgical has issued a letter to affected customers recommending that specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set be removed from where they are used or sold | Medical Devices |
| August 21, 2026 | Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits | New | FDA reports that Medline has issued a letter to affected customers recommending all lots of affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits be removed from where they are used or sold | Medical Devices |
| August 11, 2026 | HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators | Update | FDA reports that Hamilton Medical has issued a letter to affected customers recommending certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold | Medical Devices |
| July 21, 2026 | Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches | New | FDA reports that PT Organics Limited has issued a voluntary recall of select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches due to the potential for soft plastic to enter the finished product | Human Foods |
| July 20, 2026 | Cetirizine Hydrochloride tablets USP 5mg | New | FDA reports that Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) has issued a voluntary nationwide recall of cetirizine hydrochloride tablets USP 5 mg due to potential cross contamination with ranitidine | Drugs |
| July 2, 2026 | Sevoflurane and other general anesthetics | New | FDA alerts health care providers to cases of neurologic complications from general anesthesia linked to genetic variant in patients of maternal Venezuelan ancestry | Drugs |
| June 15, 2026 | SNOO X-Small and X-Large sleep sacks, SNOO Hospital Bundle, refurbished SNOO products, SNOO Smart Sleeper mattresses and/or mattress covers | New | FDA issues a warning letter to the manufacturer of the SNOO Smart Sleeper (SNOO), Happiest Baby, Inc. | Medical Devices |
| June 13, 2026 | Nara Organics Powdered Infant Formula | New | FDA reports that Nara Organics is voluntarily recalling all lots of Nara Organics Powdered Infant Formula due to the potential risk of Clostridium botulinum contamination
| Infant Formula |
| June 11, 2026 | Volara System patient circuits | New | FDA reports that Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all Volara System patient circuits be corrected prior to continued use
| Medical Devices |
| June 5, 2026 | Infant Resuscitation Systems and Warmers with a M1091607-R blender | New | FDA reports that GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use | Medical Devices |
| June 5, 2026 | Up & Up Fragrance Free and Fresh Cucumber Scented Baby Wipes | New | FDA reports that Target has recalled Up & Up Fragrance Free and Fresh Cucumber Scented Baby Wipes due to potential microbial contamination | Cosmetics |
| June 4, 2026 | Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct | New | FDA reports that Haleon has issued a voluntary nationwide recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct | Drugs |
| June 4, 2026 | Omnipod® 5 Automated Insulin Delivery System, Omnipod DASH® Insulin Management System, and Omnipod® Insulin Management System (Omnipod Eros) | Update | FDA reports that Insulet has issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold | Medical Devices |
| May 29, 2026 | Certain lots of Dexcom G7 sensors | New | FDA reports that Dexcom has uncovered theft of scrapped product, notifies potentially impacted users | Medical Devices |
| May 29, 2026 | KayserBett IDA Beds | New | FDA reports a pediatric care bed correction: KayserBetten issues correction for KayserBett IDA Beds | Medical Devices |
| May 28, 2026 | Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal | Update | FDA reports that Philips has issued new recommendations and clarified the reasons for the recall of Trilogy Evo Platform Ventilators | Medical Devices |
| May 27, 2026 | DE DIOS’S popsicles food treats | New | FDA reports that DE DIOS’S ICE POPS II LLC has issued an allergy alert on undeclared milk, pecans, pistachio, yellow #5, and red #40 in popsicles | Human Foods |
| May 12, 2026 | MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream | New | FDA reports that Pharmacal has issued a nationwide recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream due to microbial contamination | Drugs |
| May 11, 2026 | Tazverik (tazemetostat) | New | FDA alerts health care providers and patients about increased risk of new blood cancers with Tazverik (tazemetostat) use; sponsor to voluntarily withdraw product from market | Drugs |
| May 5, 2026 | TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO blood glucose monitoring systems | Update | FDA reports that Trividia Health has provided an important update to the medical device labeling correction for all TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO blood glucose monitoring systems | Medical Devices |
| May 2, 2026 | a2 Platinum USA Label Infant Formula | New | FDA reports that a2 Platinum USA Label Infant Formula is being recalled because of possible health risk
| Infant Formula |
| March 4, 2026 | Anti-choking devices | New | FDA encourages the public to follow established choking rescue protocols | Medical Devices |
| February 13, 2026 | “Tippy Toes” Brand apple pear banana | New | FDA reports that IF Copack LLC dba Initiative Foods recalls “Tippy Toes” Brand apple pear banana because of possible health risk | Human Foods |
| February 5, 2026 | Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors | Update | FDA reports that Abbott Diabetes Care has issued a glucose monitor sensor recall removing certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors
| Medical Devices |
| January 28, 2026 | Gerber Product Arrowroot Biscuits | New | FDA reports that Gerber Products Company announces a voluntary recall of limited batches of Arrowroot Biscuits out of an abundance of caution due to potential presence of foreign material following supplier recall
Human Foods
| Human Foods |
| December 29, 2025 | Dexcom G6 and G6 Pro software | New | FDA reports that Dexcom issues correction for Dexcom G6 and G6 Pro software
| Medical Devices |
| December 10, 2025 | ByHeart Whole Nutrition infant formula products | Update | FDA reports that the outbreak investigation of infant botulism is ongoing. Do not use ByHeart Whole Nutrition infant formula | Infant Formula |
| December 10, 2025 | Certain ground cinnamon products | Update | FDA reports that more ground cinnamon products added to FDA public health alert due to presence of elevated levels of lead | Human Foods |
| October 31, 2025 | Unapproved fluoride drug products | New | FDA acts to protect children from unapproved fluoride drug products
| Drugs |
| September 23, 2025 | Sprouts Organics sweet potato apple and spinach, 3.5-ounce pouch | Update | FDA reports that Sprout Organics is expanding the voluntary recall of sweet potato apple and spinach to include additional lot codes | Human Foods |
| September 16, 2025 | Unauthorized infant devices for monitioring vital signs | New | FDA warns consurmers, caregivers, and health care providers not to use unathorized infant devices for monitoring vital signs | Medical Devices |
| September 15, 2025 | Certain t-slim X2 insulin pumps | New | FDA reports that Tandem Diabetes Care issued a correction for certain t:slim X2 insulin pumps due to risk for faulty speaker wiring that may cause malfunction and stop insulin delivery | Medical Devices |
| September 12, 2025 | Dexcom G77 apps and ONE+ apps | Update | FDA reports that Dexcom, Inc. issued a correction for G7 apps and ONE+ apps due to a software design error that does not alert users of unexpected sensor failure | Medical Devices |
| September 2, 2025 | Nicotine pouches | New | FDA urges nicotine pouch manufacturers to use child-resistant packaging following increasing reports of accidental exposure | Tobacco Products |
| August 29, 2025 | Coaxial breath circuit set | New | FDA reports that Hamilton Medical, Inc. has recalled certain lots of the coaxial breathing circuit sets due to possible inner blue tube cracks that may impact ventilation | Medical Devices |
| August 28, 2025 | 4-N-1, DermaCerin, DermaFungal, DermaKleen, DermaMed, DermaSarra, Gel Rite, Hand E Foam, KleenFoam, Lantiseptic, PeriGiene, PeriGuard, Renew Dimethicone, Renew Periprotect, Renew Skin Repair, Ultrasure | New | FDA reports that DermaRite Industries has expanded a voluntary nationwide recall due to potential Burkholderia cepacia contamination
| Drugs |
| August 28, 2025 | HAMILTON-C6 ventilators | New | FDA reports that Hamilton Medical AG has issued a correction for HAMILTON-C6 ventilators due to risk of ventilation interruption from defective circuit board | Medical Devices |
| August 25, 2025 | Hyperbaric oxygen therapy devices | New | FDA reminds health care providers to follow instructions for safe use of hyperbaric oxygen therapy devices - Letter to Health Care Providers | Medical Devices |
| August 12, 2025 | t:slim X2 insulin pumps | New | FDA reports that Tandem Diabetes Care has issued a voluntary medical device correction for select t:slim X2 insulin pumps | Medical Devices |
| July 9, 2025 | AirLife/Vyaire infant heated wire circuits | New | FDA reports an infant breathing system recall: AirLife/Vyaire removes infant heated wire circuits due to risk for inadvertent adapter disconnection during ventilation | Medical Devices |
| June 30, 2025 | Extended-release stimulants for ADHD | New | FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD | Drugs |
| June 25, 2025 | Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) | New | FDA approves required updated warning in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis following vaccination | Vaccines |
| June 24, 2025 | ELEVIDYS (delandistrogene moxeparvovec-rokl) | New | FDA investigates deaths due to acute liver failure in non-ambulatory Duchenne Muscular Dystrophy patients following ELEVIDYS | Biologics |
| June 18, 2025 | Transderm Scōp (scopolamine transdermal system) | New | FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system) | Drugs |
| June 17, 2025 | Medline Neonatal and Pediatric Convenience Kits containing Smiths Medical ORAL/NASAL endotracheal tubes | New | FDA reports that Medline Industries, LP, has issued a Convenience Kit recall for removing Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL endotracheal tubes due to smaller than expected tube diameter that may cause underventilation | Medical Devices |
| June 11, 2025 | Select Newport™ HT70 and Newport™ HT70 Plus ventilators and certain related Newport™ service parts | New | FDA reports that Medtronic has announced a voluntary recall of select Newport™ HT70 and Newport™ HT70 Plus ventilators and certain related Newport™ service parts | Medical Devices |
| June 6, 2025 | Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs | New | FDA reports that Church & Dwight Co., Inc. has issued a voluntary nationwide recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs due to microbial contamination | Drugs |
| June 4, 2025 | Nitrous oxide products | Update | FDA advises consumers not to inhale nitrous oxide products | Human Foods |
| May 16, 2025 | Cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names) | New | FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names) | Drugs |
| March 11, 2025 | Limited number of acne products containing benzoyl peroxide | New | FDA alerts the public and industry that a limited number of voluntary recalls have been initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination | Drugs |
| February 5, 2025 | Diabetes-related smartphone device alert settings | New | FDA alerts patients to regularly check diabetes-related smartphone device alert settings, especially following phone hardware or software changes | Medical Devices |
| January 31, 2025 | Gerber® Soothe N Chew® Teething Sticks | New | FDA reports that Gerber Products Company announces recall and discontinuation of all batches of Gerber® Soothe N Chew® Teething Sticks due to choking hazard | Human Foods |
| January 16, 2025 | Neonatal incubators | Update | FDA provides an update: Evaluation of airborne chemicals from neonatal incubators - Letter to Health Care Providers | Medical Devices |
| December 5, 2024 | E-cigarettes | New | FDA warns more than 100 retailers for illegal sale of youth appealing e-cigarettes, including Geek Bar | Tobacco Products |
| October 30, 2024 | Disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devices | New | FDA warns firms illegally selling e-cigarettes resembling products with smart technology, including phones and gaming devices | Tobacco Products |
| October 28, 2024 | Dynacare Baby Powder | Update | FDA reports that Dynarex Corporation is expanding a recall to include additional products due to possible health risk | Cosmetics |
| October 17, 2024 | Medtronic MiniMed 600 and 700 Series insulin pumps | New | FDA reports an insulin pump recall: Medtronic notifies users of MiniMed 600 and 700 Series pumps of risk of shorter than expected battery life | Medical Devices |
| October 15, 2024 | Zyno Medical Z-800, Z-800F, Z-800W, and Z800WF infusion pumps | New | FDA reports an infusion pump recall: Zyno Medical removes Z-800, Z-800F, Z-800W, and Z800WF infusion pumps due to an air-in-line software defect that may allow larger than expected air bubbles to enter patients | Medical Devices |
| October 7, 2024 | Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields | New | FDA reports that Youngstown Grape Distributors Inc. is recalling Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields because of possible health risk | Human Foods |
| October 7, 2024 | Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators | New | FDA reports that Philips Respironics has issued additional usage instructions for Trilogy Evo ventilators related to use of in-line nebulizers | Medical Devices |
| September 5, 2024 | FreeStyle Libre® 3 sensors | Update | FDA reports continuous glucose monitoring (CGM) sensor recall: Abbott Diabetes Care Inc issues recall for certain FreeStyle Libre 3 sensors due to risk for inaccurate high glucose readings | Medical Devices |
| September 4, 2024 | Bivona® Tracheostomy Tubes | New | FDA reports that Smiths Medical issues urgent medical device notification informing customers of a potential issue with certain Bivona® Tracheostomy Tubes | Medical Devices |
| October 16, 2024 | Cue Health COVID-19 tests | Update | FDA warns home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 tests due to risk of false results | Medical Devices |
