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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 684 of 1191

FDA device recalls, page 684 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0491-2015	Class II	Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory...	Integra LifeSciences Corporation	LFL	2014-09-29
Z-0155-2015	Class II	Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine...	MEDLINE INDUSTRIES, LP - Northfield	NNW	2014-09-29
Z-0166-2015	Class II	CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF...	Abbott Medical	MEA	2014-09-29
Z-0143-2015	Class II	Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the...	Merge Healthcare Incorporated	DQK	2014-09-29
Z-0476-2015	Class II	Dharma Cavity Varnish 15mL	Dharma Research/Medeco International	LBH	2014-09-29
Z-0475-2015	Class II	Dharma Cavity Varnish with Fluoride	Dharma Research/Medeco International	LBH	2014-09-29
Z-0039-2018	Class II	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF...	Teleflex Medical	GDZ	2014-09-26
Z-0162-2015	Class II	Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic...	Merit Medical Systems, Inc.	KRA	2014-09-26
Z-0164-2015	Class II	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack...	Siemens Healthcare Diagnostics Inc.	JIX	2014-09-26
Z-0124-2015	Class II	Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a...	Cook Medical LLC	KNW	2014-09-26
Z-0500-2015	Class II	Amerigel Saturated Gauze Dressing Wound management	Amerx Health Care Corp.	MGQ	2014-09-26
Z-0499-2015	Class II	Amerigel Daily Dressing Packets Wound management	Amerx Health Care Corp.	MGQ	2014-09-26
Z-0498-2015	Class II	Amerigel Post-op Surgical Kits Wound management	Amerx Health Care Corp.	MGQ	2014-09-26
Z-0497-2015	Class II	Amerigel Hydrogel Wound Dressing Wound management	Amerx Health Care Corp.	MGQ	2014-09-26
Z-0149-2015	Class II	Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation...	Tecan U.S.	JQW	2014-09-26
Z-0058-2015	Class II	Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are...	Zimmer GmbH	HXQ	2014-09-26
Z-0057-2015	Class II	Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to...	Zimmer GmbH	HWQ	2014-09-26
Z-0056-2015	Class II	Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to...	Zimmer GmbH	HWQ	2014-09-26
Z-0168-2015	Class II	COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator)...	IBA Dosimetry GmbH	IYE	2014-09-25
Z-0126-2015	Class II	Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by...	Bausch & Lomb Incorporated	LYL	2014-09-25
Z-0146-2015	Class II	ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo...	Roche Diagnostics GmbH	LZG	2014-09-25
Z-0174-2015	Class II	Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number...	Straumann USA, LLC	DZE	2014-09-24
Z-0151-2015	Class II	Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device...	Joerns Healthcare	FNL	2014-09-24
Z-0148-2015	Class II	siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension...	Siemens Healthcare Diagnostics Inc.	DIP	2014-09-24
Z-1280-2016	Class II	Foot Switches used with the following systems: Philips Allura Xper Systems; 722001...	Philips North America LLC	IZI	2014-09-24
Z-0075-2015	Class II	Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow...	Zimmer GmbH	HWT	2014-09-24
Z-1279-2016	Class II	Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes...	Philips North America LLC	KPR	2014-09-24
Z-0059-2015	Class II	Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog...	Sterilmed Inc	OWQ	2014-09-24
Z-0183-2015	Class II	Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego...	Siemens Medical Solutions USA, Inc.	IZI	2014-09-23
Z-0577-2015	Class II	Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single...	Invacare GmbH	CAW	2014-09-23
Z-0109-2015	Class II	Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW...	Whiteside Biomechanics, Inc.	LPH	2014-09-23
Z-0073-2015	Class II	ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug...	Ameditech, Inc.	DKZ	2014-09-23
Z-0072-2015	Class II	ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug...	Ameditech, Inc.	DKZ	2014-09-23
Z-0071-2015	Class II	ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug...	Ameditech, Inc.	DKZ	2014-09-23
Z-0202-2015	Class II	GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during...	Medacta USA, Inc.	HSB	2014-09-22
Z-1064-2015	Class II	Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.	Virtual Imaging, Inc.	IZL	2014-09-22
Z-0140-2015	Class II	Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size...	C P Medical Inc.	NEW	2014-09-22
Z-0125-2015	Class I	Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The...	Endologix LLC	MIH	2014-09-20
Z-0117-2015	Class II	Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article...	Straumann USA, LLC	DZE	2014-09-19
Z-0122-2015	Class II	IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388...	Siemens Healthcare Diagnostics Inc.	CGR	2014-09-19
Z-0062-2015	Class II	MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat...	TORNIER Inc.	LXH	2014-09-19
Z-0083-2015	Class II	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor...	Siemens Healthcare Diagnostics Inc.	JIL	2014-09-19
Z-0082-2015	Class II	External power supply adaptors that accompany Clinitek Status Connect System The...	Siemens Healthcare Diagnostics Inc.	JIL	2014-09-19
Z-0081-2015	Class II	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status...	Siemens Healthcare Diagnostics Inc.	JIL	2014-09-19
Z-0060-2015	Class II	GE Healthcare Carescape Patient Data Module	GE Healthcare	MHX	2014-09-19
Z-0467-2015	Class II	Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the...	Biomerica	JKR	2014-09-18
Z-0178-2015	Class II	Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR...	Novosci Corp	DTL	2014-09-18
Z-0086-2015	Class II	Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is...	Siemens Medical Solutions USA, Inc.	MUE	2014-09-18
Z-0070-2015	Class II	V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help...	KCI USA, Inc.	OMP	2014-09-18
Z-0076-2015	Class II	Multi-Lumen Central Venous Catheterization Kit	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2014-09-18