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Browse Device Recalls

162 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 162 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 162 FDA device recalls.

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DateProductReasonClassFirm
Jul 22, 2015 Synthes Application Instrument for Sternal ZIPFIX; indications for use includ... The end cap may loosen and detach making the instrument non-functional. No injuries reported. Class II Synthes (USA) Products LLC
Jul 1, 2015 Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap ... The wrap is for single use for nail sterilization but does not have sufficient testing for the de... Class II Synthes (USA) Products LLC
Jul 1, 2015 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic m... The possibility exists for intraoperative reamer head breakages which could also allow for un-ret... Class II Synthes (USA) Products LLC
Jun 24, 2015 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and... It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. Class II Synthes (USA) Products LLC
Jun 24, 2015 Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synth... The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have... Class II Synthes (USA) Products LLC
Jun 10, 2015 Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intend... The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversiz... Class II Synthes (USA) Products LLC
Nov 6, 2014 Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electr... The device may operate solely in reverse mode, not operate in reverse mode when intended, not fun... Class II Synthes (USA) Products LLC
Oct 23, 2014 Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: T... Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws... Class I Synthes (USA) Products LLC
Oct 14, 2013 Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm... Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve f... Class II Synthes (USA) Products LLC
Jul 30, 2013 Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for frac... A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. Class II Synthes (USA) Products LLC
May 31, 2013 Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... Class II Synthes (USA) Products LLC
May 31, 2012 Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right ... USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong pa... Class II Synthes (USA) Products 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.