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 649 of 1191

FDA device recalls, page 649 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0062-2016	Class II	regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0061-2016	Class II	regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0060-2016	Class II	regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0059-2016	Class II	regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0058-2016	Class II	regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0057-2016	Class II	regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0056-2016	Class II	regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0055-2016	Class II	regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0054-2016	Class II	regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0053-2016	Class II	regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0052-2016	Class II	regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0051-2016	Class II	regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0050-2016	Class II	regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0049-2016	Class II	regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0048-2016	Class II	regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0047-2016	Class II	regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0046-2016	Class II	regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0045-2016	Class II	regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0044-2016	Class II	regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0043-2016	Class II	regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0042-2016	Class II	regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0041-2016	Class II	regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0040-2016	Class II	regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0039-2016	Class II	regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0038-2016	Class II	regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0037-2016	Class II	regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0036-2016	Class II	regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0035-2016	Class II	regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0034-2016	Class II	regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0033-2016	Class II	regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0032-2016	Class II	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0031-2016	Class II	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0030-2016	Class II	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0029-2016	Class II	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0139-2017	Class II	Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0028-2016	Class II	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-1723-2015	Class II	Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis...	Vilex LLC	HSB	2015-04-22
Z-1722-2015	Class II	Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis...	Vilex LLC	HSB	2015-04-22
Z-1721-2015	Class II	Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis...	Vilex LLC	HSB	2015-04-22
Z-1798-2015	Class II	Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.	Zimmer GmbH	HRY	2015-04-22
Z-1734-2015	Class II	AccuChek Spirit insulin infusion pump.	Roche Diabetes Care, Inc.	LZG	2015-04-22
Z-1733-2015	Class II	AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.	Roche Diabetes Care, Inc.	LZG	2015-04-22
Z-1987-2015	Class II	Philips GoSafe Communicator 7000L Personal emergency response system.	Lifeline Systems, Inc.	ILQ	2015-04-22
Z-1623-2015	Class II	CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head...	GE Healthcare	JAK	2015-04-22
Z-1677-2015	Class II	Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on...	Abbott Diagnostics Scarborough, Inc.	OCC	2015-04-22
Z-1577-2015	Class II	Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN...	GE Healthcare	DSI	2015-04-21
Z-1674-2015	Class II	EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm...	DePuy Spine, Inc.	NKB	2015-04-21
Z-1610-2015	Class III	Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical...	Zimmer Surgical SA	GCY	2015-04-21
Z-1838-2015	Class II	PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a...	Hitachi High-Tech America, Inc. Radiation Therapy Division	LHN	2015-04-21
Z-2042-2015	Class II	Upper Extremity Pack - contains Devon Light Glove Used during surgery	Gyn-Disposables, Inc.	LRO	2015-04-20