Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

Clear
DateProductReasonClassFirm
May 24, 2013 Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub... Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Pro... Class II Fresenius Medical Care Holdings, Inc.
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated
May 17, 2013 BASE, S-LIFT Instrument Case Product Usage: System cases are designed to... The S-LIFT Instrument Case contained a bracket with peeling nylon coating. Class II SpineFrontier, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Catheter and Accessories ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Cathe... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Uniti... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Cat... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Cathet... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 104936... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitr... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitative... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intende... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conju... Device design. Class II SpineFrontier, Inc.
May 7, 2013 MEDITECH Bi-Directional interactive Communication Analyzer Interface; Int... Incorrect transmission of laboratory results. Class II Medical Information Technology, Inc.
May 7, 2013 InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Us... Potential for set screw to be come deformed. Class II SpineFrontier, Inc.
Apr 25, 2013 Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... Class II Hologic, Inc.
Apr 25, 2013 S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are... Malfunction of slap hammer. Class II SpineFrontier, Inc.
Apr 25, 2013 Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... Class II Hologic, Inc.
Apr 22, 2013 Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan ... Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were... Class II SpineFrontier, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 15, 2013 DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 12, 2013 Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
Apr 12, 2013 Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
Apr 10, 2013 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... Class II Philips Medical Systems, Inc.
Apr 9, 2013 HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8... Class II Instrumentation Laboratory Co.
Apr 8, 2013 Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product I... Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... Class II Covidien LLC
Apr 8, 2013 HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. Class II Philips Healthcare Inc.
Apr 8, 2013 Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Produ... Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... Class II Covidien LLC
Apr 4, 2013 Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.
Apr 4, 2013 Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of or... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 18, 2013 Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intend... If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended volt... Class II Integra Burlington MA, Inc.
Mar 18, 2013 LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 18, 2013 NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a cas... Product may be mislabeled. Class II NxStage Medical, Inc.
Mar 18, 2013 Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 14, 2013 Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserter... Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fal... Class II SpineFrontier, 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.