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Consumer Safety

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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Dec 18, 2019 Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - ... 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 1 30 VIOLET GS-22, Item Code CL885 - Produ... 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 2-0 UNDYED 30" V-20, Item Code GL323 - 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 3/0 30 VIOLET GS-11, Item Code CL815 - 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 2/0 30 VIOLET GS-21, Item Code CL811 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 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 3/0 30" UNDYED V-20, Item Code GLS322 - Pr... 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 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr... 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 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 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 (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 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
Dec 11, 2019 Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 1... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYND... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- I86625 DEBRIDEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEME... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICA... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Suture Tray DYNDR1210A SUTURING TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- PT225 PAIN MANAGEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN) Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRAC... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP41... 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.