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 624 of 1191

FDA device recalls, page 624 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0217-2016	Class II	Envoy 500 system includes the following product reference numbers and names...	VitalScientific	CGA	2015-09-22
Z-0216-2016	Class II	ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize...	VitalScientific	CGA	2015-09-22
Z-0215-2016	Class II	Eon 300 system includes the following product reference numbers and names: Reference no...	VitalScientific	CGA	2015-09-22
Z-0214-2016	Class II	Eon 100 system included the following product reference numbers and names: Reference no...	VitalScientific	CGA	2015-09-22
Z-0164-2016	Class II	Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement...	Sentinel CH SpA	JIF	2015-09-22
Z-0193-2016	Class II	Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and...	Integra Pain Management	FMF	2015-09-22
Z-0078-2017	Class II	TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for...	BIOCOMPATIBLES U.K. Limited, a BTG Company	NAW	2015-09-21
Z-0674-2016	Class II	Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000...	Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)	CAF	2015-09-21
Z-0362-2016	Class II	Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is...	Howmedica Osteonics Corp	JWH	2015-09-21
Z-0594-2016	Class II	BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and...	ZimVie US Corp LLC	NDP	2015-09-21
Z-0593-2016	Class II	BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H...	ZimVie US Corp LLC	NDP	2015-09-21
Z-0592-2016	Class II	BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255...	ZimVie US Corp LLC	DZE	2015-09-21
Z-0591-2016	Class II	BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET...	ZimVie US Corp LLC	DZE	2015-09-21
Z-0195-2016	Class II	Custom Pak 9319-27. Single-use medical devices and accessories designed by medical...	Alcon Laboratories	LRO	2015-09-21
Z-0126-2016	Class II	Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to...	Synthes (USA) Products LLC	HSB	2015-09-21
Z-0218-2016	Class II	Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The...	Brainlab, Inc.	LLZ	2015-09-21
Z-0127-2016	Class II	4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2015-09-18
Z-2682-2016	Class II	Philips DuraDiagnost stationary X-ray system	Philips North America LLC	KPR	2015-09-17
Z-0232-2016	Class II	Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to...	Boston Scientific Corporation	LWS	2015-09-17
Z-0114-2016	Class II	Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP...	Stryker Craniomaxillofacial Division	FSM	2015-09-17
Z-0160-2016	Class II	BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single...	Diametrics Medical, Inc.	CHL	2015-09-16
Z-0159-2016	Class II	CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are...	Diametrics Medical, Inc.	CHL	2015-09-16
Z-0023-2016	Class II	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives...	GE Healthcare	LLZ	2015-09-16
Z-0165-2016	Class II	Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the...	Encore Medical, LP	OIY	2015-09-16
Z-0022-2016	Class II	Medtronic Medical Device Identification Card for SureScan pacemaker patients...	Medtronic, Inc.	DTB	2015-09-15
Z-0112-2016	Class II	Monaco Radiation Treatment Planning System. Used to make treatment plans for patients...	Elekta Limited	MUJ	2015-09-15
Z-0131-2016	Class II	AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is...	Encore Medical, LP	PHX	2015-09-15
Z-0180-2016	Class II	Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP...	Encore Medical, LP	HWA	2015-09-14
Z-0178-2016	Class II	Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional...	Philips North America LLC	JAK	2015-09-14
Z-0177-2016	Class II	Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended...	Philips North America LLC	JAK	2015-09-14
Z-0176-2016	Class II	Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce...	Philips North America LLC	JAK	2015-09-14
Z-0175-2016	Class II	Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional...	Philips North America LLC	JAK	2015-09-14
Z-0174-2016	Class II	Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional...	Philips North America LLC	JAK	2015-09-14
Z-0173-2016	Class II	Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce...	Philips North America LLC	JAK	2015-09-14
Z-0024-2016	Class II	Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and...	Synthes (USA) Products LLC	LXH	2015-09-14
Z-0179-2016	Class II	Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are...	Encore Medical, LP	HWA	2015-09-14
Z-0253-2016	Class III	MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product...	CooperSurgical, Inc.	HHW	2015-09-14
Z-0371-2016	Class II	Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol...	Valeant Pharmaceuticals North America LLC	CAF	2015-09-14
Z-0328-2016	Class III	CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage...	Biochemical Diagnostics Inc	JJX	2015-09-14
Z-2824-2015	Class II	P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857...	Medtronic Navigation, Inc	HAW	2015-09-14
Z-2823-2015	Class II	P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA...	Medtronic Navigation, Inc	OLO	2015-09-14
Z-0263-2016	Class II	Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.	Samsung HME America, Inc.	IZI	2015-09-14
Z-0152-2016	Class II	PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF...	Abbott Medical	LJT	2015-09-14
Z-2214-2017	Class III	Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and...	Neogen Culture Media	JSK	2015-09-11
Z-0402-2016	Class II	One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.	Boston Scientific Corporation	KGC	2015-09-11
Z-0113-2016	Class II	MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection...	OLYMPUS Corporation of the Americas	FEQ	2015-09-11
Z-0117-2016	Class II	NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data...	Medtronic, Inc.	GWQ	2015-09-11
Z-0363-2016	Class II	DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2)...	DeRoyal Industries, Inc.	LRO	2015-09-10
Z-0231-2016	Class II	VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-09-10
Z-0158-2016	Class II	Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number...	Smith & Nephew, Inc.	HWE	2015-09-10