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 784 of 1190

FDA device recalls, page 784 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0443-2013	Class II	Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the...	Parks Medical Electronics Inc	DPW	2012-08-08
Z-0658-2013	Class II	AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The...	ZOLL Circulation, Inc.	DRM	2012-08-08
Z-2239-2012	Class II	Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT...	Philips North America LLC	KPS	2012-08-08
Z-1942-2013	Class II	GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are...	GE Healthcare	IZL	2012-08-07
Z-2410-2012	Class III	ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack)...	Siemens Healthcare Diagnostics Inc.	CGJ	2012-08-07
Z-2409-2012	Class III	ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog...	Siemens Healthcare Diagnostics Inc.	CFT	2012-08-07
Z-2277-2012	Class III	16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an...	Bard Access Systems, Inc.	MSD	2012-08-07
Z-0223-2015	Class II	Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The...	Nidek Incorporated	LZS	2012-08-06
Z-0782-2013	Class II	Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal...	Synthes GmbH	KWQ	2012-08-06
Z-0610-2013	Class II	Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF...	Howmedica Osteonics Corp	LXH	2012-08-06
Z-0445-2013	Class II	The Is-anti-Sm test kits**Catalog No: 720-240* Product Usage: The Diamedix Is-anti-Sm...	Diamedix Corp.	LLL	2012-08-06
Z-2461-2012	Class II	Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria...	Invacare GmbH	KMN	2012-08-06
Z-0781-2013	Class II	Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal...	Synthes GmbH	KWQ	2012-08-06
Z-2405-2012	Class II	Precise Digital Accelerator Delivery of radiation to defined target volumes	Elekta Limited	IYE	2012-08-06
Z-0557-2013	Class II	ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one...	ThyssenKrupp Access Corp	ILK	2012-08-06
Z-0895-2013	Class II	Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The...	Orthofix SRL	HSB	2012-08-06
Z-0761-2013	Class II	GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System	GE Healthcare	JAC	2012-08-03
Z-0119-2013	Class II	Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are...	ZimVie US Corp LLC	DZE	2012-08-03
Z-2392-2012	Class II	Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-2391-2012	Class II	Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-2390-2012	Class II	Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-2389-2012	Class II	Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-2388-2012	Class II	Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-2387-2012	Class II	Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully...	Instrumentation Laboratory Co.	GKP	2012-08-03
Z-0057-2013	Class I	Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE...	Ethicon Endo-Surgery Inc	GDW	2012-08-03
Z-2250-2012	Class I	Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product...	Newport Medical Instruments, Inc.	CBK	2012-08-03
Z-2379-2012	Class II	HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead...	Medtronic, Inc.	GEI	2012-08-03
Z-0253-2013	Class III	Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro...	Siemens Healthcare Diagnostics Inc.	LPS	2012-08-03
Z-2245-2012	Class II	The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems...	Philips North America LLC	JAK	2012-08-03
Z-2179-2012	Class II	Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site...	Medical Specialties Distributors, Inc.	FPA	2012-08-03
Z-1480-2013	Class II	E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology	Kreg Medical Inc.	OSI	2012-08-02
Z-2346-2012	Class II	Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira...	Abbott Medical	MEA	2012-08-02
Z-2325-2012	Class III	100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes...	STERIS Corporation	LRT	2012-08-02
Z-2285-2012	Class III	PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM...	Phadia AB	MID	2012-08-02
Z-0450-2013	Class II	GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray...	GE Healthcare	IZL	2012-08-01
Z-0449-2013	Class II	GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray...	GE Healthcare	IZL	2012-08-01
Z-0448-2013	Class II	GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray...	GE Healthcare	IZL	2012-08-01
Z-2335-2012	Class II	The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant...	STERIS Corporation	MED	2012-08-01
Z-2301-2012	Class II	DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits...	Medtronic, Inc.	GEI	2012-08-01
Z-0188-2013	Class III	cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems...	Roche Molecular Systems Inc	OWD	2012-07-31
Z-2260-2012	Class I	V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60...	Respironics, Inc.	MNT	2012-07-31
Z-2217-2012	Class II	DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it...	Depuy Orthopaedics Inc.	OOM	2012-07-31
Z-0030-2013	Class II	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay...	Siemens Healthcare Diagnostics Inc.	DLZ	2012-07-30
Z-2463-2012	Class II	DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through...	Dental Imaging Technologies Corporation	LLZ	2012-07-30
Z-0470-2013	Class II	Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF...	Howmedica Osteonics Corp	LXH	2012-07-27
Z-0469-2013	Class II	Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF...	Howmedica Osteonics Corp	LXH	2012-07-27
Z-0138-2013	Class II	AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic...	Nipro Medical Corporation	DQX	2012-07-27
Z-0137-2013	Class II	AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic...	Nipro Medical Corporation	DQX	2012-07-27
Z-0136-2013	Class II	AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic...	Nipro Medical Corporation	DQX	2012-07-27
Z-0135-2013	Class II	AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic...	Nipro Medical Corporation	DQX	2012-07-27