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 683 of 1191

FDA device recalls, page 683 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1597-2016	Class II	INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718...	Alcon Laboratories	HQC	2014-10-06
Z-0673-2016	Class II	Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part...	MWT Materials, Inc.	LNH	2014-10-06
Z-0672-2016	Class II	Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part...	MWT Materials, Inc.	LNH	2014-10-06
Z-0671-2016	Class II	Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product...	MWT Materials, Inc.	LNH	2014-10-06
Z-0670-2016	Class II	Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio...	MWT Materials, Inc.	LNH	2014-10-06
Z-0669-2016	Class II	Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency...	MWT Materials, Inc.	LNH	2014-10-06
Z-0668-2016	Class II	Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product...	MWT Materials, Inc.	LNH	2014-10-06
Z-0667-2016	Class II	Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency...	MWT Materials, Inc.	LNH	2014-10-06
Z-0666-2016	Class II	Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio...	MWT Materials, Inc.	LNH	2014-10-06
Z-0665-2016	Class II	Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency...	MWT Materials, Inc.	LNH	2014-10-06
Z-0664-2016	Class II	Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product...	MWT Materials, Inc.	LNH	2014-10-06
Z-0663-2016	Class II	Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product...	MWT Materials, Inc.	LNH	2014-10-06
Z-0877-2015	Class II	Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during...	Perouse Medical	MAV	2014-10-06
Z-0876-2015	Class II	Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use...	Perouse Medical	MAV	2014-10-06
Z-0837-2015	Class II	DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP...	Datascope Corp.	MHX	2014-10-06
Z-0803-2015	Class II	Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP...	Howmedica Osteonics Corp	LXH	2014-10-06
Z-0939-2015	Class II	HomeChoice Automated PD system and HomeChoice Pro Automated PD system...	Baxter Healthcare Corporation	FKX	2014-10-06
Z-0229-2015	Class III	ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of...	Siemens Healthcare Diagnostics Inc.	NBC	2014-10-06
Z-0176-2015	Class II	UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for...	Siemens Healthcare Diagnostics Inc.	JJE	2014-10-06
Z-0175-2015	Class II	Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No...	Siemens Healthcare Diagnostics Inc.	JJE	2014-10-06
Z-0152-2015	Class II	Laksell Gamma Knife Perfexion	Elekta Limited	IWB	2014-10-06
Z-0165-2015	Class II	UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is...	Zimmer Surgical SA	HAB	2014-10-06
Z-0228-2015	Class II	FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01...	Monteris Medical Corp	GEX	2014-10-03
Z-0227-2015	Class II	SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01...	Monteris Medical Corp	GEX	2014-10-03
Z-0195-2015	Class II	Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film...	GE Healthcare	OWB	2014-10-03
Z-0194-2015	Class II	FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging...	GE Healthcare	OXO	2014-10-03
Z-0193-2015	Class II	OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the...	GE Healthcare	OXO	2014-10-03
Z-0192-2015	Class II	OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film...	GE Healthcare	OWB	2014-10-03
Z-0105-2015	Class II	Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A...	Philips North America LLC	HGM	2014-10-03
Z-0104-2015	Class II	Philips IntelliVue Monitors with software revisions J.21.03, J.21.19...	Philips North America LLC	MHX	2014-10-03
Z-1948-2015	Class II	Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in...	Zimmer GmbH	JWH	2014-10-02
Z-0092-2015	Class II	DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715	Synthes GmbH	GAD	2014-10-02
Z-0150-2015	Class II	APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated...	Medartis AG	HWC	2014-10-01
Z-0154-2015	Class II	Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No...	ZimVie US Corp LLC	DZE	2014-10-01
Z-0153-2015	Class II	Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant...	ZimVie US Corp LLC	DZE	2014-10-01
Z-0204-2015	Class II	Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and...	Compass Health Brands (Distribution Center)	ITJ	2014-10-01
Z-0180-2015	Class I	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA...	Medtronic, Inc.	CBK	2014-10-01
Z-0112-2015	Class I	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital...	Medtronic, Inc.	CBK	2014-10-01
Z-0094-2015	Class II	Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm...	Zimmer GmbH	JDI	2014-10-01
Z-0144-2015	Class II	IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic...	IMRIS Imaging, Inc.	FQO	2014-10-01
Z-0213-2015	Class II	Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that...	Masimo Corporation	DQA	2014-09-30
Z-0208-2015	Class III	CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01...	CooperSurgical, Inc.	HHW	2014-09-30
Z-0207-2015	Class III	CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01...	CooperSurgical, Inc.	HHW	2014-09-30
Z-0420-2015	Class II	Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex...	Siemens Healthcare Diagnostics Inc.	LCP	2014-09-30
Z-0111-2015	Class II	Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral...	Whiteside Biomechanics, Inc.	JWH	2014-09-30
Z-0051-2015	Class II	StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457	Boston Scientific Corporation	GEX	2014-09-30
Z-0050-2015	Class II	StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455	Boston Scientific Corporation	GEX	2014-09-30
Z-0049-2015	Class II	StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453	Boston Scientific Corporation	GEX	2014-09-30
Z-1004-2015	Class III	VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-09-29
Z-0812-2015	Class II	ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant)...	4WEB Inc.	MAX	2014-09-29