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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Apr 22, 2016 BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filte... The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. ... Class II Natus Medical Incorporated
Apr 22, 2016 Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sle... Potential for a product defect where the cannula may be obstructed. This obstruction could preve... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Apr 22, 2016 BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-... Smiths Medical became aware that under delivery of medication may occur on CADD Administration Se... Class II Smiths Medical ASD, Inc.
Apr 22, 2016 Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the ep... There is a possibility that the needles may have the potential to skive a catheters outer coatin... Class II Epimed International, Inc.
Apr 22, 2016 BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. ... Class II Acumedia Manufacturers, Inc.
Apr 22, 2016 BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Bio... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens ... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biogr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Bi... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph Tr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemen... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103... Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing AP... Class II Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Apr 22, 2016 BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bot... Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling proc... Class II Draeger Medical, Inc.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile.... During an FDA inspection it was found that the products are marketed without a cleared 510k, nor ... Class II Miami Fat Supply, Inc
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indica... AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an... Class II Musculoskeletal Transplant Foundation, 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.