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 576 of 1191

FDA device recalls, page 576 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2331-2016	Class II	Spirit Plus Bed, A-C Powered Hospital Bed	CHG Hospital Beds Inc	FNL	2016-06-28
Z-2325-2016	Class II	BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases...	BK Medical ApS	IYN	2016-06-28
Z-0135-2017	Class II	CORE Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and...	ConMed Corporation	GBW	2016-06-27
Z-0134-2017	Class II	CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE...	ConMed Corporation	GBW	2016-06-27
Z-0133-2017	Class II	CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog...	ConMed Corporation	GBW	2016-06-27
Z-0132-2017	Class II	CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number...	ConMed Corporation	GBW	2016-06-27
Z-0131-2017	Class II	CORE Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single...	ConMed Corporation	GAZ	2016-06-27
Z-0130-2017	Class II	CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or...	ConMed Corporation	GBW	2016-06-27
Z-0129-2017	Class II	CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags...	ConMed Corporation	GBW	2016-06-27
Z-2713-2016	Class II	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for...	Medtronic, Inc.	CBT	2016-06-27
Z-2755-2016	Class II	Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical...	Aspen Surgical Puerto Rico Corp.	GES	2016-06-27
Z-2247-2016	Class II	The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System...	Siemens Healthcare Diagnostics Inc.	LDT	2016-06-27
Z-2324-2016	Class II	V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into...	Zimmer GmbH	LXH	2016-06-27
Z-2323-2016	Class II	V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into...	Zimmer GmbH	LXH	2016-06-27
Z-2322-2016	Class II	TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into...	Zimmer GmbH	LXH	2016-06-27
Z-2321-2016	Class II	TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into...	Zimmer GmbH	LXH	2016-06-27
Z-0747-2017	Class II	Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item...	Revvity Health Sciences, Inc.	JQW	2016-06-24
Z-2784-2016	Class I	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light...	The Anspach Effort, Inc.	HWE	2016-06-24
Z-2783-2016	Class I	Light Adaptor for Small Battery Drive and Small Battery Drive II.	The Anspach Effort, Inc.	HWE	2016-06-24
Z-2537-2016	Class I	Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489...	Cook Incorporated	DQX	2016-06-24
Z-2238-2016	Class II	2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in...	Stryker Corp.	HBE	2016-06-24
Z-2533-2016	Class II	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes...	Baxter Healthcare Corporation	DXZ	2016-06-24
Z-2252-2016	Class II	BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for...	Becton, Dickinson and Company, BD Biosciences	GKZ	2016-06-24
Z-2530-2016	Class II	Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile...	Danville Materials, Inc.	EIA	2016-06-24
Z-2291-2016	Class II	Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion...	Etac A/S	FSA	2016-06-24
Z-1904-2021	Class II	Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026...	Philips Medical Systems Nederland B.V.	OWB	2016-06-23
Z-2549-2016	Class II	Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying...	Datascope Corp.	MHX	2016-06-23
Z-2377-2016	Class II	Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808...	Howmedica Osteonics Corp	JWH	2016-06-23
Z-2388-2016	Class II	EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A...	EDAN Diagnostics, Inc.	MHX	2016-06-23
Z-2245-2016	Class II	Syngo.via, picture archiving and communications system software controlled. Intended to...	Siemens Medical Solutions USA, Inc.	LLZ	2016-06-23
Z-2390-2016	Class II	Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock...	Howmedica Osteonics Corp	MBH	2016-06-23
Z-2150-2016	Class II	Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam...	Varian Medical Systems, Inc.	IYE	2016-06-23
Z-2149-2016	Class II	Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's...	Varian Medical Systems, Inc.	IYE	2016-06-23
Z-2645-2016	Class II	DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and...	Medtronic Neuromodulation	MHY	2016-06-23
Z-0138-2017	Class II	OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector	OLYMPUS Corporation of the Americas	FEB	2016-06-23
Z-2264-2016	Class II	Container fill and transfer sets, 250 mL and 500 mL, . .	The Metrix Company	NEP	2016-06-23
Z-2263-2016	Class II	Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL...	The Metrix Company	NEP	2016-06-23
Z-2262-2016	Class II	Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL	The Metrix Company	NEP	2016-06-23
Z-2261-2016	Class II	Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL...	The Metrix Company	NEP	2016-06-23
Z-2260-2016	Class II	Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.	The Metrix Company	NEP	2016-06-23
Z-2259-2016	Class II	AUTOCOMP6 High Speed Compounder	The Metrix Company	NEP	2016-06-23
Z-2258-2016	Class II	AUTOCOMP6 XP High Speed Compounder REF 58810	The Metrix Company	NEP	2016-06-23
Z-2257-2016	Class II	AUTOCOMP6 XPS High Speed Compounder REF 58810	The Metrix Company	NEP	2016-06-23
Z-1499-2017	Class II	Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial...	Securitas Healthcare LLC	ILQ	2016-06-22
Z-0313-2017	Class III	VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro...	Ortho-Clinical Diagnostics, Inc.	MJX	2016-06-22
Z-2255-2016	Class II	Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X...	Evident Scientific MIS, Inc.	RBY	2016-06-22
Z-2289-2016	Class II	AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier...	LeMaitre Vascular Inc.	FZP	2016-06-22
Z-2288-2016	Class II	AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier...	LeMaitre Vascular Inc.	FZP	2016-06-22
Z-2287-2016	Class II	AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier...	LeMaitre Vascular Inc.	FZP	2016-06-22
Z-2286-2016	Class II	AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier...	LeMaitre Vascular Inc.	FZP	2016-06-22