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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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Sc... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fi... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 20, 2017 Intellicuff Standalone (PN 951001) Used to continuously measure and automa... Issue related to the performance of the motor in recalled product. During use, motor may cease to... Class II Hamilton Medical, Inc.
Jun 20, 2017 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Vers... The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal a... Class II Beckman Coulter Inc.
Jun 20, 2017 Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog... Abutments are unable to accept the final abutment screw Class II Keystone Dental Inc
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 19, 2017 Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... Software- scheduled A-QC analysis could initiate prior to a patient result being released by the... Class II Nova Biomedical Corporation
Jun 19, 2017 iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... Incorrect PEC values. Class II Elekta, Inc.
Jun 19, 2017 Nussloch GmbH ASP6025 Tissue Processor Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. Class II Leica Microsystems, Inc.
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 16, 2017 ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem ... Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with S... Class II Zimmer Biomet, Inc.
Jun 16, 2017 CS 100 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 100i Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 300 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalo... An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. Class II Keystone Dental Inc
Jun 15, 2017 Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Plum 360 Infusion System Potential for the Connectivity Engine Module of the affected unit to disengage from the main chas... Class II ICU Medical Inc
Jun 15, 2017 Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001... Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. Class II Boston Scientific Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary ... A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 15, 2017 Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation

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.