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Browse Device Recalls

432 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 432 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 432 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Dec 26, 2019 Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Dec 26, 2019 Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Dec 26, 2019 Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Dec 26, 2019 Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Dec 26, 2019 Kangaroo 924 Safety Screw Spike Set, Product Code 775759 The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Dec 26, 2019 Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health Inc.
Nov 14, 2019 Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... Class II Cardinal Health Inc.
Nov 14, 2019 S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... Class II Cardinal Health Inc.
Nov 14, 2019 Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... Class II Cardinal Health Inc.
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 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 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
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, ... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen cont... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar ... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 ... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 18, 2019 DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which... Class II DeRoyal Industries Inc
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
Nov 16, 2018 Presource Kit Total Joint Pack containing a double-wrapped basin component. ... The double wrapping of this custom kit basin set is not supported by the current sterility assura... Class II Cardinal Health Inc.
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

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.