Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2606-2015 | Class II | MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2605-2015 | Class II | CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OHM | |
| Z-2604-2015 | Class II | O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OHD | |
| Z-2603-2015 | Class II | PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OKV | |
| Z-2602-2015 | Class II | OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OFA | |
| Z-2601-2015 | Class II | LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OKV | |
| Z-2600-2015 | Class II | CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OHM | |
| Z-2599-2015 | Class II | LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | FDE | |
| Z-2598-2015 | Class II | FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2597-2015 | Class II | RETINA PACK 7/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJK | |
| Z-2596-2015 | Class II | UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | KKX | |
| Z-2595-2015 | Class II | Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | FYA | |
| Z-2594-2015 | Class II | LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures... | Customed, Inc | FYA | |
| Z-2593-2015 | Class II | DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | MCY | |
| Z-2592-2015 | Class II | UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | KNX | |
| Z-2591-2015 | Class II | FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical... | Customed, Inc | KNX | |
| Z-2590-2015 | Class II | LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2589-2015 | Class II | D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | FDE | |
| Z-2588-2015 | Class II | ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OEQ | |
| Z-2587-2015 | Class II | E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OGR | |
| Z-2586-2015 | Class II | IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OJH | |
| Z-2585-2015 | Class II | UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | KNX | |
| Z-2584-2015 | Class II | WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2583-2015 | Class II | UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical... | Customed, Inc | LRO | |
| Z-2582-2015 | Class II | PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2581-2015 | Class II | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OFA | |
| Z-2580-2015 | Class II | PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2579-2015 | Class II | NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OJG | |
| Z-2578-2015 | Class II | PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical... | Customed, Inc | HRX | |
| Z-2577-2015 | Class II | PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OKV | |
| Z-2576-2015 | Class II | PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical... | Customed, Inc | LRO | |
| Z-2575-2015 | Class II | PREMIUM CESAREAN PACK CUSTOMED 5/CS Used by medical staff to perform surgical... | Customed, Inc | OHM | |
| Z-2574-2015 | Class II | LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2573-2015 | Class II | WOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical procedures... | Customed, Inc | LRO | |
| Z-2572-2015 | Class II | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OFA | |
| Z-2571-2015 | Class II | LAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OHD | |
| Z-2570-2015 | Class II | LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | FDE | |
| Z-2569-2015 | Class II | WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2568-2015 | Class II | NEURO PACK 3/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OJG | |
| Z-2567-2015 | Class II | FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures... | Customed, Inc | NWR | |
| Z-2566-2015 | Class II | FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical... | Customed, Inc | NWR | |
| Z-2565-2015 | Class II | TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures... | Customed, Inc | NXA | |
| Z-2564-2015 | Class II | PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OHD | |
| Z-2563-2015 | Class II | ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and... | Customed, Inc | HRX | |
| Z-2562-2015 | Class II | PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OHD | |
| Z-2561-2015 | Class II | LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | FDE | |
| Z-2560-2015 | Class II | ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | HRX | |
| Z-2559-2015 | Class II | OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | MLS | |
| Z-2558-2015 | Class II | CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform... | Customed, Inc | FAJ | |
| Z-2557-2015 | Class II | WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical... | Customed, Inc | MCY |