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-0387-2015 | Class I | Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0386-2015 | Class I | Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0385-2015 | Class I | Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0384-2015 | Class I | Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0383-2015 | Class I | Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0382-2015 | Class I | Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0381-2015 | Class I | Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient... | Customed, Inc | OKV | |
| Z-0380-2015 | Class I | Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient... | Customed, Inc | FDE | |
| Z-0379-2015 | Class I | Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care... | Customed, Inc | OHM | |
| Z-0378-2015 | Class I | Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0377-2015 | Class I | Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care... | Customed, Inc | OHM | |
| Z-0376-2015 | Class I | Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient... | Customed, Inc | KKX | |
| Z-0375-2015 | Class I | Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0374-2015 | Class I | Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by... | Customed, Inc | KKX | |
| Z-0373-2015 | Class I | Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0372-2015 | Class I | Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0371-2015 | Class I | Breast Pack Used by medical staff to perform patient care procedures such as wound... | Customed, Inc | LRO | |
| Z-0370-2015 | Class I | Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0369-2015 | Class I | Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0368-2015 | Class I | Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0367-2015 | Class I | Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical... | Customed, Inc | OJH | |
| Z-0366-2015 | Class I | ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures... | Customed, Inc | OJG | |
| Z-0365-2015 | Class I | Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0364-2015 | Class I | Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0363-2015 | Class I | Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0362-2015 | Class I | Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0361-2015 | Class I | Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0360-2015 | Class I | Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by... | Customed, Inc | OJH | |
| Z-0359-2015 | Class I | Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to... | Customed, Inc | LRO | |
| Z-0358-2015 | Class I | Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0357-2015 | Class I | Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0356-2015 | Class I | Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care... | Customed, Inc | OFA | |
| Z-0355-2015 | Class I | Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0354-2015 | Class I | Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0353-2015 | Class I | Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0352-2015 | Class I | Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care... | Customed, Inc | FWZ | |
| Z-0351-2015 | Class I | Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform... | Customed, Inc | KKX | |
| Z-0350-2015 | Class I | OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such... | Customed, Inc | OKV | |
| Z-0349-2015 | Class I | Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0348-2015 | Class I | Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures... | Customed, Inc | LRO | |
| Z-0347-2015 | Class I | Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures... | Customed, Inc | LRO | |
| Z-0346-2015 | Class I | Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0345-2015 | Class I | Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0344-2015 | Class I | Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0343-2015 | Class I | Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient... | Customed, Inc | FDE | |
| Z-0342-2015 | Class I | Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care... | Customed, Inc | KKX | |
| Z-0341-2015 | Class I | Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0340-2015 | Class I | Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0339-2015 | Class I | Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0338-2015 | Class I | Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care... | Customed, Inc | OJF |