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 606 of 1191

FDA device recalls, page 606 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1437-2016	Class II	Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform...	Customed, Inc	KKX	2016-01-07
Z-1436-2016	Class II	Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1435-2016	Class II	Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1434-2016	Class II	Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1433-2016	Class II	Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1432-2016	Class II	Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1431-2016	Class II	Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1430-2016	Class II	Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform...	Customed, Inc	KKX	2016-01-07
Z-1429-2016	Class II	Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical...	Customed, Inc	MCY	2016-01-07
Z-1428-2016	Class II	Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1427-2016	Class II	Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1426-2016	Class II	Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	OGR	2016-01-07
Z-1425-2016	Class II	Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to...	Customed, Inc	LRO	2016-01-07
Z-1424-2016	Class II	Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical...	Customed, Inc	MCY	2016-01-07
Z-1423-2016	Class II	Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1422-2016	Class II	Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1421-2016	Class II	Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJG	2016-01-07
Z-1420-2016	Class II	Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1419-2016	Class II	Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to...	Customed, Inc	OKV	2016-01-07
Z-1418-2016	Class II	Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1417-2016	Class II	Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical...	Customed, Inc	OHM	2016-01-07
Z-1416-2016	Class II	Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical...	Customed, Inc	OJH	2016-01-07
Z-1415-2016	Class II	Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1414-2016	Class II	Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1413-2016	Class II	Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used...	Customed, Inc	NWR	2016-01-07
Z-1412-2016	Class II	Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used...	Customed, Inc	NWR	2016-01-07
Z-1411-2016	Class II	Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by...	Customed, Inc	NXA	2016-01-07
Z-1410-2016	Class II	Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1409-2016	Class II	Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	OJH	2016-01-07
Z-1408-2016	Class II	Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1407-2016	Class II	Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	FAJ	2016-01-07
Z-1406-2016	Class II	Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical...	Customed, Inc	MCY	2016-01-07
Z-1405-2016	Class II	Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical...	Customed, Inc	MCY	2016-01-07
Z-1404-2016	Class II	Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1403-2016	Class II	Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform...	Customed, Inc	LRO	2016-01-07
Z-1402-2016	Class II	Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical...	Customed, Inc	LRO	2016-01-07
Z-1401-2016	Class II	Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK	Customed, Inc	LRO	2016-01-07
Z-1400-2016	Class II	Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical...	Customed, Inc	KYZ	2016-01-07
Z-1399-2016	Class II	Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical...	Customed, Inc	OKV	2016-01-07
Z-1398-2016	Class II	Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical...	Customed, Inc	MCZ	2016-01-07
Z-1397-2016	Class II	Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform...	Customed, Inc	KKX	2016-01-07
Z-1524-2016	Class II	Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length...	Synthes (USA) Products LLC	KWQ	2016-01-06
Z-0802-2016	Class I	Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are...	Cook Incorporated	DQY	2016-01-06
Z-0801-2016	Class I	Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays...	Cook Incorporated	DQY	2016-01-06
Z-0800-2016	Class I	Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised...	Cook Incorporated	DQY	2016-01-06
Z-0799-2016	Class I	Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are...	Cook Incorporated	DQY	2016-01-06
Z-0696-2016	Class II	ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall...	Global Healthcare, Inc.	FPA	2016-01-06
Z-0784-2016	Class II	IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product...	ZimVie US Corp LLC	DZE	2016-01-06
Z-0783-2016	Class II	IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product...	ZimVie US Corp LLC	DZE	2016-01-06
Z-0782-2016	Class II	IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product...	ZimVie US Corp LLC	DZE	2016-01-06