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FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·May 6, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·May 6, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·April 15, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·April 15, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Philips Spectral CT on Rails. Model Number: 728334.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·April 22, 2026

Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026