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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Clear
DateProductReasonClassFirm
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 ... Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sampl... Class II Siemens Healthcare Diagnostics, Inc.
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code:... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si S... Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... Class II Intuitive Surgical, Inc.
May 6, 2013 VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage:... There is evidence that an electrical short within the systems connector has caused an accumulatio... Class II Ortho-Clinical Diagnostics
May 6, 2013 RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... Multiple studies were missing at a customer location that never made it to the archive before wat... Class II Merge Healthcare, Inc.
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONB... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... Product did not reach expected sterility assurance level Class II The Anspach Effort, Inc.
May 6, 2013 VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product cod... There is evidence that an electrical short within the systems connector has caused an accumulatio... Class II Ortho-Clinical Diagnostics
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Produ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide... Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing,... Class II Alphatec Spine, Inc.
May 6, 2013 VITROS 5600 Integrated System (product code 6802413) Product Usage: For ... There is evidence that an electrical short within the systems connector has caused an accumulatio... Class II Ortho-Clinical Diagnostics
May 6, 2013 Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Produc... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical... Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... Class II Intuitive Surgical, Inc.
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 F... There is evidence that an electrical short within the systems connector has caused an accumulatio... Class II Ortho-Clinical Diagnostics
May 6, 2013 ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... There is evidence that an electrical short within the systems connector has caused an accumulatio... Class II Ortho-Clinical Diagnostics
May 4, 2013 NIPRO Safe Touch Safety Scalp Vein Set There is a possibility of a crack in the CP luer connector. The position of the crack is at the c... Class II Nipro Medical Corporation
May 3, 2013 - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Dril... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 12244... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Nee... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlle... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0m... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manua... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 DePuy Glenosphere orientation guide Product Usage: The glenosphere o... The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being ... Class II DePuy Orthopaedics, Inc.
May 3, 2013 - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Hea... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink)... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 20... ConMed was notified by the contract manufacturer that their wire/connector supplier reported dama... Class II ConMed Corporation
May 3, 2013 TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-1... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen,... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308,... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DV... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm R... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 2, 2013 Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417)... The product has the potential for false negative or delayed reaction for Arginine (ARG) results. ... Class II Siemens Healthcare Diagnostics, Inc.
May 2, 2013 Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal groupin... The product may give weak or false negative test results. Class II Remel Inc
May 2, 2013 Mobiletta Mira Mobile X-ray System Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett... Class II Siemens Medical Solutions USA, Inc
May 2, 2013 Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal g... The product may give weak or false negative test results. Class II Remel Inc
May 2, 2013 GE Healthcare, Precision 500D Product Usage: The Precision 500D is design... GE Healthcare has recently become aware of a potential safety issue involving the overhead Video ... Class II GE Healthcare, LLC
May 2, 2013 Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: ... Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0... Class II Merit Medical Systems, Inc.
May 1, 2013 CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421... Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification Class II CooperSurgical, Inc.
May 1, 2013 BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes... BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw vo... Class II Becton Dickinson & Company

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.