Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Dec 22, 2023 HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 22, 2023 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Nov 30, 2023 Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 30, 2023 Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 30, 2023 Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 28, 2023 External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 28, 2023 EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 16, 2023 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... Class II Covidien LP
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DY... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYN... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TR... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CD... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSOR... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF D... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/B... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS9839... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTO... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT,... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC050... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KI... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, la... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10F... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ9... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF V... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield

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.