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Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

Clear
DateProductReasonClassFirm
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.
Dec 5, 2019 Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instrum... Instrument can break at the level of the thread when being exposed to high forces during nail imp... Class II Stryker GmbH
Nov 28, 2019 aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 The company has become aware that the soft tissue retractor is not always removed during the sawi... Class II AAP Implantate Ag
Nov 21, 2019 ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): ... The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... Class II Radiometer Medical ApS
Nov 21, 2019 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... Pin To Rod Coupling could not clamp the pin and rod as intended Class II Stryker GmbH
Nov 21, 2019 ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R052... The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... Class II Radiometer Medical ApS
Nov 18, 2019 There is a complaint regarding internal check cable guide mechanism failure f... A component failure may lead to treatment interruption or incorrect source positioning. Class II Nucletron BV
Nov 5, 2019 Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer... The Autostainer instrument may not have a syringe tray installed which could result in a small vo... Class II Dako Denmark A/S
Nov 4, 2019 Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apo... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled ta... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-cont... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Nov 4, 2019 Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray ... An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... Class II Villa Sistemi Medicali S.P.A.
Oct 11, 2019 MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... Class II AMD Medicom Inc.
Oct 11, 2019 MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... Class II AMD Medicom Inc.
Oct 9, 2019 Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V A... The firm has identified that packaging containing components of the hip replacement range are mi... Class II Signature Orthopaedics Europe Ltd
Oct 7, 2019 Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to... Class II The Binding Site Group, Ltd.
Oct 7, 2019 NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... There is a remote potential for the sterile packaging of the transseptal guiding sheath to be com... Class II Baylis Medical Company 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.