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 823 of 1190

FDA device recalls, page 823 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2357-2012	Class I	CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2356-2012	Class I	CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2355-2012	Class I	CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2354-2012	Class I	CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2353-2012	Class I	CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2352-2012	Class I	CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2351-2012	Class I	CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2350-2012	Class I	CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-2349-2012	Class I	CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The...	Custom Medical Specialties, Inc.	LRO	2011-09-30
Z-0820-2012		EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical...	PENTAX of America, Inc.	EOX	2011-09-30
Z-0819-2012		EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of...	PENTAX of America, Inc.	EOX	2011-09-30
Z-0818-2012		EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical...	PENTAX of America, Inc.	EOQ	2011-09-30
Z-0170-2012		Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health...	Medtronic, Inc.	LRP	2011-09-30
Z-0169-2012		Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal...	Medtronic, Inc.	LRO	2011-09-30
Z-0460-2012		SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number...	Synthes (USA) Products LLC	MQV	2011-09-29
Z-0180-2012		i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement...	Abbott Medical	MMI	2011-09-29
Z-0159-2012		"*BIOMET 3i4555 Riverside Drive Palm Beach Gardens FL 33410 USA**REF...	ZimVie US Corp LLC	NHA	2011-09-28
Z-0158-2012		"*BIOMET 3i4555 Riverside Drive Palm Beach Gardens FL 33410 USA**REF...	ZimVie US Corp LLC	NHA	2011-09-28
Z-0151-2012		RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument...	Encore Medical, LP	LXH	2011-09-28
Z-0150-2012		RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument...	Encore Medical, LP	LXH	2011-09-28
Z-0341-2012		TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The...	Radiometer America, Inc	LKD	2011-09-27
Z-0258-2012		Precedence System; SYST,PRECEDENCE, 6 SLICE 5/8 Manufactured by Philips Medical Systems...	Philips North America LLC	KPS	2011-09-27
Z-0257-2012		Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems...	Philips North America LLC	KPS	2011-09-27
Z-0256-2012		Precedence System; SYST,PRECEDENCE, 16 SLICE 3/8 Manufactured by Philips Medical Systems...	Philips North America LLC	KPS	2011-09-27
Z-0255-2012		Precedence System; SYST,PRECEDENCE, 16 SLICE 5/8 Manufactured by Philips Medical Systems...	Philips North America LLC	KPS	2011-09-27
Z-0254-2012		SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,5/8 Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0253-2012		SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,3/8 Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0252-2012		SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,5/8 Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0251-2012		SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,3/8 Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0250-2012		SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0249-2012		SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0248-2012		SKYLight Gamma Camera System; SKYLIGHT 8FT, 5/8" SPECT Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0247-2012		SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical...	Philips North America LLC	KPS	2011-09-27
Z-0372-2012		Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe...	Gentherm Medical, LLC	BZT	2011-09-26
Z-0280-2012		Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.	Inova Diagnostics, Inc.	DHN	2011-09-26
Z-0103-2012		Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692...	Hamilton Co	JJE	2011-09-26
Z-0105-2012		OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen...	Carl Zeiss Meditec Inc	EPT	2011-09-26
Z-0208-2012		ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an...	Lifewatch Services, Inc.	DXH	2011-09-26
Z-0207-2012		LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated...	Lifewatch Services, Inc.	DXH	2011-09-26
Z-0206-2012		LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system...	Lifewatch Services, Inc.	DXH	2011-09-26
Z-1425-2013	Class II	Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover...	Intuitive Surgical, Inc.	NAY	2011-09-23
Z-2472-2012	Class II	Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow...	Medtronic, Inc.	KRA	2011-09-23
Z-2471-2012	Class II	UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The...	Medtronic, Inc.	KRA	2011-09-23
Z-2071-2012	Class II	Product is labeled in part: "*OPTETRAK RBKTIBIAL TRAYFINNED, CEMENTED*CoCr...	Exactech, Inc.	NJL	2011-09-23
Z-2070-2012	Class II	Product is labeled in part: "*OPTETRAKTIBIAL TRAYTRAPEZOID CEMENTED*Ti...	Exactech, Inc.	JWH	2011-09-23
Z-0430-2012		Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a...	Abbott Medical	DXY	2011-09-23
Z-0429-2012		Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers...	Abbott Medical	DXY	2011-09-23
Z-0213-2012		DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland...	CooperSurgical, Inc.	KGI	2011-09-23
Z-0082-2012		Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage...	Smith & Nephew, Inc.	GCJ	2011-09-23
Z-0113-2012		Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B...	Invivo Corporation	MWI	2011-09-23