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.

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DateProductReasonClassFirm
Sep 25, 2018 DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305... Incorrect package labeling identifying the device Class II DT MedTech, LLC
Sep 25, 2018 PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... Class II Pro-Dex Inc
Sep 25, 2018 Panda Freestanding Warmer. Device sold under the following product names: Pa... Potential electric leakage affecting the user. Class II GE Healthcare, LLC
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Produ... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Giraffe Incubator Carestation. Neonatal incubator. Device sold under the fol... Potential electric leakage affecting the user. Class II GE Healthcare, LLC
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114... Incorrect package labeling identifying the device Class II DT MedTech, LLC
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 24, 2018 Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... Class II Invivo Corporation
Sep 24, 2018 PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fi... Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3... Class II PerkinElmer Health Sciences Canada, Inc.
Sep 24, 2018 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... Class II Johnson & Johnson Surgical Vision Inc
Sep 24, 2018 Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Pro... Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 u... Class II Roche Diagnostics Corporation
Sep 24, 2018 BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 ... A trend for false positive Candida glabrata results has been confirmed. The discrepant results i... Class II Becton Dickinson & Co.
Sep 24, 2018 BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Pr... A trend for false positive Candida glabrata results has been confirmed. The discrepant results i... Class II Becton Dickinson & Co.
Sep 21, 2018 Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset... Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting ... Class II Encore Medical, Lp
Sep 21, 2018 BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos... The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ... Class III Becton Dickinson & Co.
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Conne... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage:... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: T... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, ... Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5... Class II RAYSEARCH LABORATORIES AB
Sep 21, 2018 CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Us... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Conne... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 in... The products labeling contains inconsistencies. In certain instances, the lidstock, banner card ... Class II Arrow International Inc
Sep 21, 2018 StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-us... There is a potential for comingling of the 43MM and 51 MM molds Class II Zimmer Biomet, Inc.
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 20, 2018 AS-OBGYN Information System version 7.824.x Any change made to current ultrasound machine software or hardware upgrades, adding or modifying ... Class II AS Software, Inc.
Sep 20, 2018 Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-0113... Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Force... Class II Micro-Tech (Nanjing) Co., Ltd.
Sep 20, 2018 Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 There is a potential for interruption and/or inability to start therapy to the patient prior to o... Class I Maquet Datascope Corp - Cardiac Assist Division
Sep 20, 2018 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 There is a potential for interruption and/or inability to start therapy to the patient prior to o... Class I Maquet Datascope Corp - Cardiac Assist Division

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.