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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 605 of 1191

FDA device recalls, page 605 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1487-2016	Class II	Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1486-2016	Class II	Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to...	Customed, Inc	OJH	2016-01-07
Z-1485-2016	Class II	Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1484-2016	Class II	Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1483-2016	Class II	Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical...	Customed, Inc	KKX	2016-01-07
Z-1482-2016	Class II	Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform...	Customed, Inc	KKX	2016-01-07
Z-1481-2016	Class II	Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1480-2016	Class II	Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform...	Customed, Inc	KKX	2016-01-07
Z-1479-2016	Class II	Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to...	Customed, Inc	LRO	2016-01-07
Z-1478-2016	Class II	Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	OKV	2016-01-07
Z-1477-2016	Class II	Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1476-2016	Class II	Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1475-2016	Class II	Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III...	Customed, Inc	FYA	2016-01-07
Z-1474-2016	Class II	Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III...	Customed, Inc	FYA	2016-01-07
Z-1473-2016	Class II	Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OHD	2016-01-07
Z-1472-2016	Class II	Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to...	Customed, Inc	OHD	2016-01-07
Z-1471-2016	Class II	Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1470-2016	Class II	Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1469-2016	Class II	Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OKV	2016-01-07
Z-1468-2016	Class II	Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OHM	2016-01-07
Z-1467-2016	Class II	Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OHM	2016-01-07
Z-1466-2016	Class II	Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1465-2016	Class II	Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1464-2016	Class II	Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OKV	2016-01-07
Z-1463-2016	Class II	Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1462-2016	Class II	Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1461-2016	Class II	Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1460-2016	Class II	Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1459-2016	Class II	Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform...	Customed, Inc	NWO	2016-01-07
Z-1458-2016	Class II	Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9%...	Customed, Inc	JOL	2016-01-07
Z-1457-2016	Class II	Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical...	Customed, Inc	OJH	2016-01-07
Z-1456-2016	Class II	Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to...	Customed, Inc	OJH	2016-01-07
Z-1455-2016	Class II	Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OFA	2016-01-07
Z-1454-2016	Class II	Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1453-2016	Class II	Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to...	Customed, Inc	OJH	2016-01-07
Z-1452-2016	Class II	Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical...	Customed, Inc	OJH	2016-01-07
Z-1451-2016	Class II	Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1450-2016	Class II	Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1449-2016	Class II	Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1448-2016	Class II	Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1447-2016	Class II	Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to...	Customed, Inc	LRO	2016-01-07
Z-1446-2016	Class II	Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical...	Customed, Inc	OJG	2016-01-07
Z-1445-2016	Class II	Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1444-2016	Class II	Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to...	Customed, Inc	OJH	2016-01-07
Z-1443-2016	Class II	Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1442-2016	Class II	Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	OJH	2016-01-07
Z-1441-2016	Class II	Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1440-2016	Class II	Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1439-2016	Class II	Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJK	2016-01-07
Z-1438-2016	Class II	Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJK	2016-01-07