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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 732 of 1191

FDA device recalls, page 732 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0941-2014	Class II	enGen Track System with enGen Select v5.0 with autoverification enabled Product The...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-10-08
Z-1709-2014	Class II	CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter...	LAP of America Laser Applications, LLC.		2013-10-07
Z-0627-2014	Class II	C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	ODP	2013-10-07
Z-0389-2014	Class II	Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product...	Datascope Corp.	MHX	2013-10-07
Z-2609-2016	Class II	1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device...	Baxter Healthcare Corporation	FKX	2013-10-07
Z-0851-2014	Class II	User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500...	Siemens Healthcare Diagnostics Inc.	JJE	2013-10-07
Z-0131-2014	Class II	GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product...	Smith & Nephew, Inc.	JWH	2013-10-07
Z-0130-2014	Class II	GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product...	Smith & Nephew, Inc.	JWH	2013-10-07
Z-0154-2014	Class II	Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34...	Medtronic, Inc.	NIQ	2013-10-07
Z-0817-2014	Class II	VITROS Chemistry Products COCM Reagent	Ortho-Clinical Diagnostics, Inc.	DIO	2013-10-04
Z-1096-2014	Class II	Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression...	Invivo Corporation	MWI	2013-10-03
Z-1233-2014	Class III	ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute...	ZimVie US Corp LLC	LYC	2013-10-03
Z-0394-2014	Class II	Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in...	Synthes GmbH	HTN	2013-10-03
Z-0369-2014	Class II	Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium...	Synthes GmbH	HSB	2013-10-03
Z-0386-2014	Class III	Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro...	Lin-Zhi International Inc	LAS	2013-10-03
Z-0434-2014	Class III	STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902...	Advanced Sterilization Products	FRG	2013-10-03
Z-0202-2014	Class II	Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument...	Synthes GmbH	LXH	2013-10-03
Z-0910-2014	Class II	MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing...	Trividia Health, Inc.	NBW	2013-10-02
Z-0909-2014	Class II	MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing...	Trividia Health, Inc.	NBW	2013-10-02
Z-0111-2014	Class II	Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive...	Intuitive Surgical, Inc.	NAY	2013-10-02
Z-0110-2014	Class II	Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The...	Intuitive Surgical, Inc.	NAY	2013-10-02
Z-0519-2014	Class II	Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in...	Siemens Healthcare Diagnostics Inc.	JJE	2013-10-02
Z-0133-2014	Class II	The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585...	EKOS Corporation	KRA	2013-10-02
Z-0092-2014	Class II	REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution...	Stryker Corp.	DZJ	2013-10-02
Z-1072-2014	Class I	GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant...	GE Healthcare	BTL	2013-10-01
Z-1071-2014	Class I	GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone...	GE Healthcare	BTM	2013-10-01
Z-1070-2014	Class I	GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant...	GE Healthcare	BTL	2013-10-01
Z-0483-2014	Class II	Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker...	Howmedica Osteonics Corp	HWC	2013-10-01
Z-0469-2014	Class II	Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital...	FUJIFILM Healthcare Americas Corporation	OTU	2013-10-01
Z-1113-2014	Class II	TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL...	Canon Medical Systems USA, Inc.	JAK	2013-10-01
Z-0128-2014	Class III	Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3	Freudenberg Medical, LLC	EWL	2013-10-01
Z-0583-2014	Class II	Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.	Howmedica Osteonics Corp	HWA	2013-09-30
Z-0582-2014	Class II	Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.	Howmedica Osteonics Corp	HWA	2013-09-30
Z-0980-2014	Class I	Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection...	Merit Medical Systems, Inc.	NGT	2013-09-30
Z-0455-2014	Class II	Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7...	Synthes GmbH	OVE	2013-09-30
Z-0282-2014	Class II	Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating...	Draeger, Inc.	FQO	2013-09-30
Z-0279-2014	Class II	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and...	Medtronic Neuromodulation	MHY	2013-09-30
Z-0278-2014	Class II	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program...	Medtronic Neuromodulation	LGW	2013-09-30
Z-0125-2014	Class II	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable...	Medtronic Neuromodulation	LGW	2013-09-30
Z-0124-2014	Class II	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program...	Medtronic Neuromodulation	LGW	2013-09-30
Z-0151-2014	Class II	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with...	Ethicon Endo-Surgery Inc	LTI	2013-09-30
Z-0150-2014	Class II	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with...	Ethicon Endo-Surgery Inc	LTI	2013-09-30
Z-0149-2014	Class II	Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with...	Ethicon Endo-Surgery Inc	LTI	2013-09-30
Z-0007-2014	Class I	Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL...	Bard Peripheral Vascular Inc	NIP	2013-09-30
Z-0559-2014	Class II	B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02...	B Braun Medical Inc	DYB	2013-09-27
Z-0081-2014	Class II	Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent...	Cordis US Corp.	DTK	2013-09-27
Z-0166-2014	Class II	OmniPod Insulin Management Product Demonstration Kit; Model Reference Number...	Insulet Corporation	LZG	2013-09-27
Z-0165-2014	Class II	OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400...	Insulet Corporation	LZG	2013-09-27
Z-0115-2014	Class II	Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze...	Afikim Electric Vehicles (S.A.E. AFIKIM)	INI	2013-09-27
Z-0432-2014	Class II	TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi...	OLYMPUS Corporation of the Americas	GEI	2013-09-27