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.

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DateProductReasonClassFirm
Nov 13, 2013 Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... Class II Karl Storz Endoscopy America Inc
Nov 13, 2013 Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... Class II Karl Storz Endoscopy America Inc
Nov 6, 2013 Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... Class II Karl Storz Endoscopy America Inc
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
Aug 16, 2012 KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manual... The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America 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.