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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 2, 2016 catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose In... Class II Becton Dickinson & Company
Oct 25, 2013 *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ... Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb... Class II Hospira Inc.
Jul 17, 2013 Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System... Class II Hospira Inc.
Jun 18, 2013 LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE... Hospira has received reports of customers experiencing air-in-line alarms related to administrati... Class II Hospira Inc.
Feb 19, 2013 Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free ... Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch ... Class II Hospira Inc.
Dec 7, 2012 Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest,... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Conn... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Aug 29, 2012 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 29, 2012 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 2, 2012 Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-0... Reports of leaking during filling and administration. Class II Hospira, Inc.
Jul 13, 2012 Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch wi... The float valve in the burette sticks to the burette wall and does not open or close properly. Class II Hospira Inc.

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.