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Browse Device Recalls

32 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 32 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 32 FDA device recalls.

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DateProductReasonClassFirm
Jul 23, 2021 Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code... Affected products were manufactured with materials found to have a bioburden level exceeding the ... Class II Aspen Surgical Products, Inc.
Jul 23, 2021 Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product cod... Affected products were manufactured with materials found to have a bioburden level exceeding the ... Class II Aspen Surgical Products, Inc.
Jul 23, 2021 Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample K... Affected products were manufactured with materials found to have a bioburden level exceeding the ... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSyste... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (1... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intend... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) In... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Jul 26, 2013 Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in.... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... Class II Aspen Surgical Products, 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.