Browse Device Recalls
1,001 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,001 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 1,001 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, 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) ASC MINOR THYROID CD... | 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) CENTRAL LINE TRAY, R... | 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) TRACH CARE 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) DIALYSIS FISTULA 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: CATHETERIZATION 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 | Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, R... | 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 L PREP, REF DYNJ69... | 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) L&B CDS-LF, REF CDS9... | 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) ASC GENERAL MINOR CD... | 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) GYN LAPAROSCOPY, REF... | 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) IV SECUREMENT 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) ER LACERATION TRAY -... | 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: C-SECTION, REF DYNJ904653G | 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 TRACH BASIC SOLUTION, REF DYND40511 | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | PVP SOLUTION SING STRL, REF DYNDA1858 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE PVP SLN KIT, REF DYNDM1097 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE STERILE PREP STICK, REF DYNDA1134 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE PVP, REF DYNDA1649 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE BETADINE, REF DYNDA1998 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE POVIDONE, REF DYNDA2061 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE PVP SOLUTION, REF DYNDA1907 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | 24 BLOOD CULTURE KIT, REF DYNDH1632 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | BLOOD CULTURE KIT, REF DYNDH1647B | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | 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.