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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zeego, Material no. 10280959 , for angiography and whole body radiogra... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zee biplane MN, Material no. 10094143, for angiography and whole body r... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 If the C-arm is manually moved in the longitudinal direction to a fully extended position, the sy... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be util... Device was marketed for uses outside the 510(k) clearance. Class II Hobbs Medical, Inc.
May 1, 2018 Artis Q ceiling, Material no. 10848281, for angiography and whole body radiog... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Artis Q biplane, Material no. 10848282, for angiography and whole body radiog... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Artis Q.zeego, Material no. 10848283, for angiography and whole body radiogra... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... The implants are mislabeled. Class II Keystone Dental Inc
May 1, 2018 Artis Q.zen floor, Material no. 10848353, for angiography and whole body radi... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0702814819... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 27, 2018 GE Healthcare Optima CT540. The systems are intended for head, whole body, c... GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... Class II GE Healthcare Japan Corporation
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0746421516... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The ... GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... Class II GE Healthcare Japan Corporation
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 GE Healthcare Optima CT660. Sold under the following product names: BEI... GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... Class II GE Healthcare Japan Corporation
Apr 27, 2018 Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 GE Healthcare Optima CT660. The systems are intended for head, whole body, c... GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... Class II GE Healthcare Japan Corporation
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator f... The valve assembly material may become corroded due to insufficient cleaning by a supplier. There... Class II Draeger Medical, Inc.
Apr 26, 2018 BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BY... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo G... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC

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.