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Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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DateProductReasonClassFirm
Dec 18, 2019 Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Prod... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - P... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
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 AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... Class II Boston Scientific Corporation
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 Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This d... The incorrect label was placed on both the primary and secondary package. Class II W L Gore & Associates, Inc.
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 Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instrument... There is a potential for blockage of the Hub Attachment Tube. Class II Arthrex, Inc.
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 17, 2019 Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168... Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ... Class II Quest Medical, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... The product contains a different plate than indicated by the package labeling. The product is lab... Class II Nextremity Solutions
Dec 16, 2019 VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/35... Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Product... Class II Ortho Clinical Diagnostics Inc
Dec 16, 2019 LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6... Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunge... Class II Smith & Nephew, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 16, 2019 Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel ... The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivat... Class II Microbiologics Inc
Dec 16, 2019 Centricity Universal Viewer 6.0, a device that displays medical images and da... Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are inco... Class II GE Healthcare, LLC
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - ... There is a possibility that the inner cap could open when the outer cap is removed or the entire ... Class II Synthes, Inc.
Dec 13, 2019 HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperatu... There is the potential for water to flood the column and enter the circuit under circumstances wh... Class I TELEFLEX MEDICAL INC
Dec 13, 2019 HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, RE... There is the potential for water to flood the column and enter the circuit under circumstances wh... Class I TELEFLEX MEDICAL INC
Dec 13, 2019 Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-1... Due to customer reports it has been determined that the inoculation system contains the incorrec... Class II Beckman Coulter Inc.
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 13, 2019 HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier... There is the potential for water to flood the column and enter the circuit under circumstances wh... Class I TELEFLEX MEDICAL INC
Dec 13, 2019 ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: E... Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). Class II CooperSurgical, Inc.
Dec 13, 2019 HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit There is the potential for water to flood the column and enter the circuit under circumstances wh... Class I TELEFLEX MEDICAL INC
Dec 12, 2019 ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8... Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... Class II Baxter Healthcare Corporation
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 12, 2019 Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... Class II Arrow International Inc
Dec 12, 2019 Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8... Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... Class II Baxter Healthcare Corporation
Dec 12, 2019 Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Mode... The lot contained two outer pins instead of one outer and one inner pin. Class II Zimmer Biomet, Inc.
Dec 11, 2019 Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMEN... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C A... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products 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.