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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Sep 21, 2023 TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ... When using affected curette and software, there is a discrepancy between the actual curette tip l... Class II Acclarent, Inc.
Nov 12, 2021 TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS0... Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specific... Class II Acclarent, Inc.
Mar 6, 2019 TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... Class II Acclarent, Inc.
Mar 6, 2019 TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... Class II Acclarent, Inc.
Mar 6, 2019 TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... Class II Acclarent, Inc.
Apr 28, 2015 RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U... Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's ... Class III Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, 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.