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Browse Device Recalls

214 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 214 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 214 FDA device recalls.

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DateProductReasonClassFirm
Aug 27, 2015 Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesth... Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during... Class II B. Braun Medical, Inc.
Mar 27, 2015 CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous... There is a potential for a hole to be present in the outer tray of a limited number of pain contr... Class II B. Braun Medical, Inc.
Aug 6, 2014 B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... Class II B. Braun Medical, Inc.
May 29, 2014 STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22... Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled... Class II B. Braun Medical, Inc.
Apr 3, 2014 Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spina... B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing th... Class II B. Braun Medical, Inc.
Jan 8, 2014 SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sit... Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Set... Class II B. Braun Medical, Inc.
Dec 13, 2013 B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used f... Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow... Class II B. Braun Medical, Inc.
Sep 27, 2013 B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 42... One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is... Class II B. Braun Medical, Inc.
Aug 5, 2013 Outlook Safety Infusion System Burette Set. For intravenous fluid administ... Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Pro... Class II B. Braun Medical, Inc.
Apr 4, 2013 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... Class II B. Braun Medical, Inc.
Apr 4, 2013 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... Class II B. Braun Medical, Inc.
Mar 1, 2013 Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to... There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over t... Class II B. Braun Medical, Inc.
Mar 23, 2012 Infusomat(R) Space Pump (US Version) with software version 686G030103 (common... Firm became aware of the potential for breakage of the anti free flow clip catch, located on the ... Class I B. Braun Medical, Inc.
Mar 23, 2012 Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. ... Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters,... Class II B. Braun Medical, 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.