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-0321-2015 | Class I | Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0320-2015 | Class I | Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0319-2015 | Class I | Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care... | Customed, Inc | OJK | |
| Z-0318-2015 | Class I | Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient... | Customed, Inc | OJH | |
| Z-0317-2015 | Class I | Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0316-2015 | Class I | Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform... | Customed, Inc | FDE | |
| Z-0315-2015 | Class I | Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care... | Customed, Inc | OJK | |
| Z-0314-2015 | Class I | Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0313-2015 | Class I | Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0312-2015 | Class I | Urology Pack, Catalog number 900-1738. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0311-2015 | Class I | Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0310-2015 | Class I | Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0309-2015 | Class I | OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care... | Customed, Inc | OHD | |
| Z-0308-2015 | Class I | Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0307-2015 | Class I | Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care... | Customed, Inc | OFA | |
| Z-0306-2015 | Class I | Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care... | Customed, Inc | OHM | |
| Z-0305-2015 | Class I | Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform... | Customed, Inc | FDE | |
| Z-0304-2015 | Class I | Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to perform patient... | Customed, Inc | OKV | |
| Z-0303-2015 | Class I | Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0302-2015 | Class I | Retina Pack, Catalog number 900-1611. Used by medical staff to perform patient care... | Customed, Inc | OJK | |
| Z-0301-2015 | Class I | Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0300-2015 | Class I | Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0299-2015 | Class I | Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0298-2015 | Class I | Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to... | Customed, Inc | OFA | |
| Z-0297-2015 | Class I | D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient... | Customed, Inc | FDE | |
| Z-0296-2015 | Class I | Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0295-2015 | Class I | Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care... | Customed, Inc | OEQ | |
| Z-0294-2015 | Class I | ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care... | Customed, Inc | OGR | |
| Z-0293-2015 | Class I | D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient... | Customed, Inc | OJH | |
| Z-0292-2015 | Class I | Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0291-2015 | Class I | Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to... | Customed, Inc | OFA | |
| Z-0290-2015 | Class I | Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform... | Customed, Inc | GBN | |
| Z-0289-2015 | Class I | Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0288-2015 | Class I | Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care... | Customed, Inc | OFA | |
| Z-0287-2015 | Class I | Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0286-2015 | Class I | Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care... | Customed, Inc | OJG | |
| Z-0285-2015 | Class I | Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0284-2015 | Class I | Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0283-2015 | Class I | Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient... | Customed, Inc | OHM | |
| Z-0282-2015 | Class I | Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care... | Customed, Inc | OJH | |
| Z-0281-2015 | Class I | Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care... | Customed, Inc | OFA | |
| Z-0280-2015 | Class I | Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform... | Customed, Inc | OHD | |
| Z-0279-2015 | Class I | Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0278-2015 | Class I | Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care... | Customed, Inc | OJG | |
| Z-0277-2015 | Class I | Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient... | Customed, Inc | NWR | |
| Z-0276-2015 | Class I | Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient... | Customed, Inc | NWR | |
| Z-0275-2015 | Class I | Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0274-2015 | Class I | Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care... | Customed, Inc | FWZ | |
| Z-0273-2015 | Class I | Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0272-2015 | Class I | Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform... | Customed, Inc | FDE |