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Browse Device Recalls

275 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 275 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 275 FDA device recalls.

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DateProductReasonClassFirm
Oct 28, 2019 Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer Private Label Item Code: 3069 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle Item code: 8881200029 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product U... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus ... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Dec 27, 2018 Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Pr... Curity All Purpose Sponges were not sterilized and distributed Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Mar 28, 2018 Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a)... products may be missing a one-way valve on the fluid patient port. Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML d... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 50... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric ... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML dev... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.