Recalls published in May 2026
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in May 2026, newest first.
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Class I · 6 months ago
American Contract Systems Inc Convenience kits containing Medline Namic Angiographic recall: Impacted kits contain syringes recalled by Medline Industries. Syringe
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection…
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Class II · 6 months ago
Medline Convenience Kits: 1) DYNDA3003 recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) SCC RF Pain Mgmt recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) Basic Nerve Block Tray W/Linen recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Physio-Control, Inc. Lifepak 15, REF: 99577-000025, 99577-000047 recall: Some defibrillators serviced between July 2023 through November 2025
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Open Heart CDS recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Centinel Spine, Inc. Prodisc C SK U.S. Implant Extra Large 5MM. Model: Pdsxl5 Total recall: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm…
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Class II · 6 months ago
Medline Convenience Kits: 1) Lithotomy Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step K in vitro diagnostic test REF: 81A4 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Medline Convenience Kits: 1) PPE KIT recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) WMC I D PACK-LF recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class I · 6 months ago
AVID Medical, Inc. Halyard Cardiac Cath Tray Shands JAX kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Plastic BIN recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 60 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class I · 6 months ago
B Braun Medical Inc Lactated Ringer's Injection USP, 1000 mL container recall: Presence of Particulate Matter
Presence of Particulate Matter.
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Class II · 6 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules USP, 60mg recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Class III · 6 months ago
Unichem Pharmaceuticals USA Inc. busPIRone Hydrochloride Tablets, USP recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 20 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
JB Chemicals and Pharmaceuticals Ltd Enalapril Maleate Tablets, USP recall: Failed Impurities/Degradation Specifications:Out of specification result
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
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Class II · 6 months ago
Acella Pharmaceuticals, LLC Naproxen Oral Suspension, USP, 125 mg/5mL recall: Chemical contamination; presence of lead and lithium above specification
Chemical contamination; presence of lead and lithium above specification
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 30 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…