Browse Device Recalls
1,300 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,300 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 1,300 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 6, 2026 | Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROO... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT,... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline ... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline ... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SK... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot C... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Numb... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medli... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF)... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Nu... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTER... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, M... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/S... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medl... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Me... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCO... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL,... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Numb... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Me... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, A... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Ki... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Ki... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: PORT A CATH DYNJ906818A | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CD... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ682... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED S... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
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.