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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

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Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... Class II Rayner Intraocular Lenses Limited
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 10, 2020 ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... Class II Radiometer Medical ApS
Mar 9, 2020 ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading t... Class II Abbott Gmbh & Co. KG
Mar 6, 2020 ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Through internal investigation is has been determined that an incorrect component was used within... Class II Radiometer Medical ApS
Mar 6, 2020 Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Ra... The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use... Class II R82 A/S
Mar 5, 2020 natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph The OBM system functional test (impedance and noise) was not carried out on the affected items pr... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Mar 4, 2020 RayStation standalone software treatment planning system, Model Numbers 4.0, ... Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtu... Class II RAYSEARCH LABORATORIES AB
Mar 2, 2020 Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-defic... Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the ... Class II CSL Behring GmbH
Feb 26, 2020 Synaptive ImageDrive Clinical A software defect negatively affects the quality of images taken during diagnostic imaging (mammo... Class II Synaptive Medical Inc
Feb 26, 2020 ClearCanvas RIS/PACS A software defect negatively affects the quality of images taken during diagnostic imaging (mammo... Class II Synaptive Medical Inc
Feb 20, 2020 TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor mo... Reports have been received about the transcutaneous monitoring system display flickering or monit... Class II Radiometer Medical ApS
Feb 18, 2020 Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Us... The firm received reports of a number of broken latches on the floorsitter. Class II James Leckey Design Ltd
Feb 18, 2020 Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Us... The control target and range value for Sodium using the ISE indirect method has been assigned inc... Class II Randox Laboratories Ltd.
Feb 11, 2020 Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - P... During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. Class II Intellijoint Surgical, Inc.
Feb 3, 2020 ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... The firm received reports of occurrences where the barcode reader misinterpreted the contents of... Class II Radiometer Medical ApS
Feb 3, 2020 ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intende... The firm received reports of occurrences where the barcode reader misinterpreted the contents of... Class II Radiometer Medical ApS
Jan 24, 2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... Class II Abbott Gmbh & Co. KG
Jan 20, 2020 FlipCutter III Drill There is potential for the blister tray to be cracked causing the sterile barrier to be compromis... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Jan 10, 2020 NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerie... Following a customer complaint about colored eluates, leading to invalid results bioMerieux has c... Class II BIOMERIEUX - Grenoble
Jan 7, 2020 Cocoon Convective Warming System, Product Code: CWS4000 (110V). Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to im... Class II Care Essentials Pty., Ltd.
Jan 7, 2020 Cocoon Convective Warming System, Product Code: CWS5000 (110V). Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to im... Class II Care Essentials Pty., Ltd.
Dec 23, 2019 Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041... The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as... Class II Jjgc Industria E Comercio De Materials Dentario...
Dec 19, 2019 RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4... Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module ma... Class II RAYSEARCH LABORATORIES AB
Dec 19, 2019 RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041... Software version UI2550642107 for the RX Daytona + instrument released to correct the following i... Class II Randox Laboratories, Limited
Dec 17, 2019 VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:871921... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) Vitre... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 13, 2019 Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Ch... Class III Randox Laboratories Ltd.
Dec 12, 2019 ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Combination of software and a component failure may cause audible alarms not to operate properly,... Class I ResMed Ltd.

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.