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 675 of 1191

FDA device recalls, page 675 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0583-2015	Class I	ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips...	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	MKJ	2014-11-11
Z-0576-2015	Class II	Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is...	Siemens Medical Solutions USA, Inc.	LLZ	2014-11-11
Z-0527-2015	Class II	Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only...	Alcon Laboratories	GEI	2014-11-11
Z-0814-2015	Class III	Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to...	Aesculap Inc	JXG	2014-11-11
Z-0496-2015	Class II	Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10)...	Cure Medical, LLC	EZD	2014-11-11
Z-1228-2015	Class III	CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application...	Medtronic, Inc.	LZG	2014-11-10
Z-0905-2015	Class II	Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable...	Depuy Orthopaedics Inc.	LXH	2014-11-10
Z-0904-2015	Class II	Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are...	Depuy Orthopaedics Inc.	LXH	2014-11-10
Z-0903-2015	Class II	Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are...	Depuy Orthopaedics Inc.	LXH	2014-11-10
Z-0953-2015	Class II	The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee...	Depuy Orthopaedics Inc.	LXH	2014-11-10
Z-2320-2015	Class II	GE Optional Laser Centering Device X-ray generator.	GE Inspection Technologies, LP	RER	2014-11-10
Z-0426-2015	Class II	GE Cabinet X-ray systems	GE Inspection Technologies, LP	RCE	2014-11-10
Z-0941-2015	Class II	CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved...	CSA Medical	GEH	2014-11-10
Z-0588-2015	Class II	MEVION S250, used for proton radiation therapy.	Mevion Medical Systems, Inc.	LHN	2014-11-10
Z-0992-2015	Class III	Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with...	Tecan U.S.	KHO	2014-11-10
Z-0991-2015	Class III	Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector...	Tecan U.S.	KHO	2014-11-10
Z-0573-2015	Class II	Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters...	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	2014-11-10
Z-0473-2015	Class II	IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade...	Philips North America LLC	JAK	2014-11-09
Z-0360-2017	Class II	SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29...	Unomedical A/S	FPA	2014-11-07
Z-0359-2017	Class II	Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"...	Unomedical A/S	FPA	2014-11-07
Z-0358-2017	Class II	Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm...	Unomedical A/S	FPA	2014-11-07
Z-0357-2017	Class II	AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs...	Unomedical A/S	FPA	2014-11-07
Z-0356-2017	Class II	Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23"...	Unomedical A/S	FPA	2014-11-07
Z-0355-2017	Class II	Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp...	Unomedical A/S	FPA	2014-11-07
Z-1411-2015	Class II	OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.	ZimVie US Corp LLC	DZE	2014-11-07
Z-1410-2015	Class II	OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.	ZimVie US Corp LLC	DZE	2014-11-07
Z-1409-2015	Class II	3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental...	ZimVie US Corp LLC	DZE	2014-11-07
Z-1816-2015	Class II	BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec...	Becton Dickinson & Co	OOI	2014-11-07
Z-0825-2015	Class II	Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to...	Depuy Orthopaedics Inc.	LZO	2014-11-07
Z-0831-2015	Class II	Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen...	Integra LifeSciences Corporation	GWM	2014-11-07
Z-0836-2015	Class II	adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged...	Ion Beam Applications S.A.	LHN	2014-11-07
Z-2094-2015	Class II	Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care	Breas Medical AB	NOU	2014-11-07
Z-0160-2018	Class II	ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard...	Zimmer GmbH	HAW	2014-11-06
Z-0848-2015	Class II	VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use...	Ortho-Clinical Diagnostics, Inc.	CDT	2014-11-06
Z-0462-2015	Class I	CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to...	ConMed Corporation	LDD	2014-11-06
Z-0461-2015	Class I	CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct...	ConMed Corporation	LDD	2014-11-06
Z-0460-2015	Class I	MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY...	ConMed Corporation	MKJ	2014-11-06
Z-0459-2015	Class I	PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0458-2015	Class I	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0457-2015	Class I	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0456-2015	Class I	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0455-2015	Class I	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0931-2015	Class II	Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is...	Synthes (USA) Products LLC	HTC	2014-11-06
Z-0454-2015	Class I	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO...	ConMed Corporation	MKJ	2014-11-06
Z-0813-2015	Class II	Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint...	Integra LifeSciences Corporation	KWD	2014-11-06
Z-0850-2015	Class III	Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system...	Illumina, Inc.	PFS	2014-11-06
Z-0530-2015	Class II	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30...	Advanced Medical Optics, Inc.	LZP	2014-11-06
Z-0210-2015	Class II	Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel...	Fisher & Paykel Healthcare, Inc.	FMT	2014-11-06
Z-2096-2015	Class II	Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case...	Manus Medical, LLC	GCB	2014-11-05
Z-0472-2015	Class II	Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software...	Canon Medical Systems USA, Inc.	JAK	2014-11-05