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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 431 of 1190

FDA device recalls, page 431 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0780-2019	Class II	Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens...	Siemens Healthcare Diagnostics Inc.	JIT	2018-09-26
Z-0408-2019	Class II	CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for...	Accuray Incorporated	IYE	2018-09-26
Z-0552-2019	Class I	StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical...	Medtronic Navigation, Inc	HAW	2018-09-26
Z-0387-2019	Class II	PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA...	Becton Dickinson & Co	FPA	2018-09-26
Z-0386-2019	Class II	PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA...	Becton Dickinson & Co	FPA	2018-09-26
Z-0391-2019	Class I	TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial...	Oscor Inc.	LDF	2018-09-26
Z-2340-2019	Class II	PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch...	Pro-Dex Inc	GEY	2018-09-25
Z-0352-2019	Class II	Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0351-2019	Class II	Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0403-2019	Class II	DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components...	DT MedTech, LLC	NTG	2018-09-25
Z-0402-2019	Class II	DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components...	DT MedTech, LLC	NTG	2018-09-25
Z-0350-2019	Class II	Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0349-2019	Class II	Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0348-2019	Class II	Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0347-2019	Class II	Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0346-2019	Class II	Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0345-2019	Class II	Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0344-2019	Class II	Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0343-2019	Class II	Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0342-2019	Class II	Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0341-2019	Class II	Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0340-2019	Class II	Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0339-2019	Class II	Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0338-2019	Class II	Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0337-2019	Class II	Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0336-2019	Class II	Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0335-2019	Class II	Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0334-2019	Class II	Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0333-2019	Class II	Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0332-2019	Class II	Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0331-2019	Class II	Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0330-2019	Class II	Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0329-2019	Class II	Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0328-2019	Class II	Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0327-2019	Class II	Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0326-2019	Class II	Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0325-2019	Class II	Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0324-2019	Class II	Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0323-2019	Class II	Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0322-2019	Class II	Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0321-2019	Class II	Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0320-2019	Class II	Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0319-2019	Class II	Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0318-2019	Class II	Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0317-2019	Class II	Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0316-2019	Class II	Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0315-2019	Class II	Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Product Usage...	Cook Medical LLC	FGE	2018-09-25
Z-0314-2019	Class II	Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The...	Cook Medical LLC	FGE	2018-09-25
Z-0484-2019	Class II	Panda Wall Mount warmer. Infant radiant warmer	GE Healthcare	FMT	2018-09-25
Z-0483-2019	Class II	Panda Freestanding Warmer. Device sold under the following product names: Panda...	GE Healthcare	FMT	2018-09-25