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 694 of 1191

FDA device recalls, page 694 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2270-2014	Class II	Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display...	Invivo Corporation	MWI	2014-06-30
Z-2111-2014	Class II	Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture...	Siemens Medical Solutions USA, Inc.	LLZ	2014-06-30
Z-2265-2014	Class II	Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set	Synthes GmbH	HWC	2014-06-30
Z-2123-2014	Class II	PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis...	Ra Medical Systems,Inc	GEX	2014-06-30
Z-2130-2014	Class II	RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile...	Teleflex Medical	CCW	2014-06-30
Z-2036-2014	Class III	Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance...	STERIS Corporation	MEC	2014-06-30
Z-2625-2014	Class II	Life Force Chamber Product Usage:The product is intended for restful contemplation and...	Life Force of Tampa, LLC	LGM	2014-06-27
Z-2134-2014	Class II	Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0)...	Brainlab, Inc.	LLZ	2014-06-27
Z-2166-2014	Class II	PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code...	Revvity Health Sciences, Inc.	JQP	2014-06-27
Z-2182-2014	Class II	Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/...	Integra LifeSciences Corporation	NKB	2014-06-27
Z-2026-2014	Class II	The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically...	STERIS Corporation	FQO	2014-06-27
Z-2562-2014	Class II	Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing...	Hill-Rom Inc.	KNC	2014-06-26
Z-2167-2014	Class II	Esaote PA230E Transducer A portable and cart base ultrasound system for general and...	Esaote North America, Inc	JOP	2014-06-26
Z-2092-2014	Class II	Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III...	Alphatec Spine, Inc.	NKB	2014-06-26
Z-0093-2015	Class II	McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete...	Mckesson Information Solutions, LLC	MWI	2014-06-25
Z-2598-2014	Class II	Merci Retriever Intended to restore blood flow in the neurovasculature by removing...	Concentric Medical, Inc.	NRY	2014-06-25
Z-2594-2014	Class II	BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are...	ZimVie US Corp LLC	NHA	2014-06-25
Z-0416-2015	Class II	MediChoice Dual-Release Folding Walker with 5" wheel	Owens & Minor Distribution, Inc.	ITJ	2014-06-25
Z-2676-2014	Class II	The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of...	Peters Surgical	GAT	2014-06-25
Z-2675-2014	Class II	The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester...	Peters Surgical	GAT	2014-06-25
Z-2093-2014	Class II	Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial...	Salter Labs	BYG	2014-06-25
Z-2039-2014	Class II	Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.	Karl Storz Endoscopy-America, Inc.	LMD	2014-06-25
Z-2050-2014	Class II	Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006	Zimmer GmbH	DZE	2014-06-25
Z-2023-2014	Class II	Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean...	Invacare GmbH	INN	2014-06-25
Z-1443-2015	Class II	Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing...	Bard Access Systems, Inc.	GDZ	2014-06-24
Z-2156-2014	Class II	Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.	Stryker Corp.	LFL	2014-06-24
Z-2146-2014	Class II	ExacTrac is intended to be used to place patients at an accurately defined point within...	Brainlab, Inc.	IYE	2014-06-24
Z-2091-2014	Class II	MK5 NX Controller--Wheelchair controller	Invacare GmbH	ITI	2014-06-24
Z-2686-2014	Class II	Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2014-06-23
Z-2212-2014	Class II	Device Brand Name: Distal Radius Fracture Repair System Device Classification Name...	Zimmer GmbH	HRS	2014-06-23
Z-2557-2014	Class II	Cordis EMPIRA RX PTCA Dilatation Catheter	Cordis US Corp.	LOX	2014-06-23
Z-2556-2014	Class II	Cordis EMPIRA NC RX PTCA Dilatation Catheter	Cordis US Corp.	LOX	2014-06-23
Z-2150-2014	Class II	SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in...	Siemens Healthcare Diagnostics Inc.	NBC	2014-06-23
Z-2149-2014	Class II	SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in...	Siemens Healthcare Diagnostics Inc.	NBC	2014-06-23
Z-1982-2014	Class II	BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel...	Philips North America LLC	KPS	2014-06-23
Z-2634-2014	Class II	BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2633-2014	Class II	BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2632-2014	Class II	BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2631-2014	Class II	BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2630-2014	Class II	BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2629-2014	Class II	BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part...	Fresenius Medical Care Renal Therapies Group, LLC	JKA	2014-06-23
Z-2073-2014	Class II	LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical...	Laser Peripherals LLC	GEX	2014-06-20
Z-2088-2014	Class II	Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic...	Accriva Diagnostics, Inc.	JPA	2014-06-20
Z-2080-2014	Class II	Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only...	Stryker Corp.	LJH	2014-06-20
Z-1946-2014	Class II	Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model...	CooperSurgical, Inc.	MQK	2014-06-20
Z-2147-2014	Class II	Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 &...	Boston Scientific Corporation	LWS	2014-06-19
Z-2169-2014	Class II	5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling...	Abbott Molecular, Inc.	JJH	2014-06-19
Z-2037-2014	Class II	GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A...	Philips North America LLC	KPS	2014-06-18
Z-2077-2014	Class II	Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09)...	GE Healthcare	CBR	2014-06-18
Z-2180-2014	Class II	Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded...	Siemens Medical Solutions USA, Inc.	IYE	2014-06-17