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 785 of 1190

FDA device recalls, page 785 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0134-2013	Class II	AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic...	Nipro Medical Corporation	DQX	2012-07-27
Z-2314-2012	Class II	TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce...	Quality Electrodynamics	MOS	2012-07-27
Z-2340-2012	Class II	Multileaf Collimator To be used for single or multiple fractions, delivered as static...	Elekta Limited	IYE	2012-07-27
Z-2398-2012	Class II	The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog...	Bio-Rad Laboratories Inc.	LOM	2012-07-27
Z-2458-2012	Class II	The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and...	Integra Lifesciences Sales LLC	FWZ	2012-07-27
Z-2224-2012	Class II	Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the...	Biomet U.K., Ltd.	IQO	2012-07-27
Z-2457-2012	Class II	The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and...	Integra Lifesciences Sales LLC	FWZ	2012-07-27
Z-2184-2012	Class II	IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and...	AGFA Healthcare Corp.	LLZ	2012-07-27
Z-1739-2013	Class II	Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in...	Abbott Medical	LGW	2012-07-26
Z-0643-2013	Class II	Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A...	Philips North America LLC	MKJ	2012-07-26
Z-1738-2013	Class II	Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system...	Abbott Medical	LGW	2012-07-26
Z-1836-2013	Class II	Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of...	Abbott Medical	LGW	2012-07-26
Z-0642-2013	Class II	Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips...	Philips North America LLC	MKJ	2012-07-26
Z-0431-2013	Class II	Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical...	DSM Biomedical, Inc.	LMF	2012-07-26
Z-2233-2012	Class II	Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-2232-2012	Class II	Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-2231-2012	Class II	Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-2230-2012	Class II	Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-2178-2012	Class II	System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-2177-2012	Class II	System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in...	Terumo Cardiovascular Systems Corporation	DTQ	2012-07-26
Z-0165-2013	Class II	Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing...	Oscor Inc.	LDF	2012-07-25
Z-2333-2012	Class II	Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and...	Aesculap Inc	NKB	2012-07-25
Z-2313-2012	Class II	Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA...	Siemens Healthcare Diagnostics Inc.	NBC	2012-07-25
Z-2207-2012	Class II	Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta...	Philips North America LLC	KPR	2012-07-25
Z-0047-2013	Class II	Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are...	Siemens Healthcare Diagnostics Inc.	JIT	2012-07-24
Z-0046-2013	Class II	Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a...	Siemens Healthcare Diagnostics Inc.	CGN	2012-07-24
Z-2312-2012	Class II	Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by...	Mirion Technologies (Capintec), Inc.	IZD	2012-07-24
Z-0685-2013	Class II	DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is...	DePuy Spine, Inc.	HXC	2012-07-24
Z-2220-2012	Class II	Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the...	Depuy Orthopaedics Inc.	LPH	2012-07-24
Z-2263-2012	Class II	Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9...	Cisco Systems Inc	NSX	2012-07-23
Z-2323-2012	Class III	VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The...	Trek Diagnostic Systems, Ltd.	MDB	2012-07-23
Z-1567-2013	Class II	CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a...	GE Healthcare	MHX	2012-07-20
Z-2261-2012	Class II	Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical...	Galil Medical Ltd.	GEH	2012-07-20
Z-2186-2012	Class III	TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research...	Teleflex Medical	GBW	2012-07-20
Z-0192-2013	Class III	Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot...	Abbott Medical	JJT	2012-07-19
Z-1538-2013	Class II	Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and...	Laserworld USA Inc	REA	2012-07-19
Z-2275-2012	Class II	syngo.plaza, Model number 10592457. Intended use: radiological image processing system.	Siemens Medical Solutions USA, Inc.	LLZ	2012-07-18
Z-2264-2012	Class II	syngo Imaging XS. Radiological image processing system.	Siemens Medical Solutions USA, Inc.	LLZ	2012-07-18
Z-2223-2012	Class II	The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems...	Philips North America LLC	JAK	2012-07-18
Z-2215-2012	Class II	00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical...	Zimmer GmbH	KWA	2012-07-18
Z-2214-2012	Class II	00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical...	Zimmer GmbH	KWA	2012-07-18
Z-2213-2012	Class II	00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle Per surgical...	Zimmer GmbH	KWA	2012-07-18
Z-2174-2012	Class I	Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide)...	Medtronic, Inc.	JOH	2012-07-18
Z-2212-2012	Class II	Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical...	Zimmer GmbH	KWA	2012-07-18
Z-2228-2012	Class II	Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number...	Siemens Healthcare Diagnostics Inc.	LIP	2012-07-17
Z-2182-2012	Class II	Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare...	Siemens Healthcare Diagnostics Inc.	JJE	2012-07-17
Z-2175-2012	Class III	Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the...	Siemens Healthcare Diagnostics Inc.	LEH	2012-07-17
Z-2201-2012	Class II	13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that...	Nico Corporation	GZT	2012-07-17
Z-2200-2012	Class II	13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that...	Nico Corporation	GZT	2012-07-17
Z-2222-2012	Class II	Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model...	ConforMIS, Inc.	JWH	2012-07-17