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 717 of 1191

FDA device recalls, page 717 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1312-2014	Class II	Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.	Philips North America LLC	MUJ	2014-02-11
Z-1269-2014	Class II	AMS AST For the In vitro quantitative determination of AST in serum Quantitative...	Ams Diagnostics	NJT	2014-02-11
Z-1268-2014	Class II	AMS URIC ACID For the In vitro quantitative determination of Uric Acid in...	Ams Diagnostics	NJT	2014-02-11
Z-1267-2014	Class II	AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in...	Ams Diagnostics	NJT	2014-02-11
Z-1457-2014	Class II	The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to...	Synthes GmbH	GAD	2014-02-11
Z-1143-2014	Class I	Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or...	Respironics, Inc.	CBK	2014-02-11
Z-2555-2014	Class II	The Thermedx Fluid Management System is designed to provide irrigation fluids to...	Thermedx LLC	OJR	2014-02-10
Z-1133-2014	Class II	BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage...	Kulzer GmbH	KZP	2014-02-10
Z-1177-2014	Class II	bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device)...	bioMerieux, Inc.	LIB	2014-02-10
Z-1241-2014	Class II	SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous...	ConvaTec Limited	KOD	2014-02-07
Z-1240-2014	Class II	'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous...	ConvaTec Limited	KOD	2014-02-07
Z-1239-2014	Class II	JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters...	ConvaTec Limited	KOD	2014-02-07
Z-1238-2014	Class II	SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex...	ConvaTec Limited	KOD	2014-02-07
Z-1448-2014	Class II	Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft)...	Orthopediatrics Canada ULC	HSB	2014-02-07
Z-1237-2014	Class II	Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage...	ConvaTec Limited	KOD	2014-02-07
Z-1236-2014	Class II	Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product...	ConvaTec Limited	KOD	2014-02-07
Z-1309-2014	Class II	Artis Zee Angiographic x-ray systems.	Siemens Medical Solutions USA, Inc.	IZI	2014-02-07
Z-1272-2014	Class II	AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography...	Siemens Medical Solutions USA, Inc.	IZI	2014-02-07
Z-1200-2014	Class II	Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product...	GE Healthcare	KPS	2014-02-07
Z-1199-2014	Class II	GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the...	GE Healthcare	KPS	2014-02-07
Z-1484-2014	Class I	SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma...	Baxter Healthcare Corporation	FRN	2014-02-07
Z-1298-2014	Class I	Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita...	Draeger Medical Systems, Inc.	CBK	2014-02-07
Z-0991-2014	Class II	MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in...	Biocardia, Inc.	DYB	2014-02-07
Z-1130-2014	Class II	FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical...	Encore Medical, LP	LPH	2014-02-07
Z-1152-2014	Class II	HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast...	Leica Biosystems Imaging, Inc.	NOT	2014-02-07
Z-1198-2014	Class II	GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head...	GE Healthcare	KPS	2014-02-07
Z-1225-2014	Class II	Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and...	Philips North America LLC	MKJ	2014-02-06
Z-1232-2014	Class II	Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)...	Philips North America LLC	MKJ	2014-02-06
Z-1179-2014	Class II	Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from...	Lin-Zhi International Inc	JJW	2014-02-06
Z-1178-2014	Class II	Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from...	Lin-Zhi International Inc	DLJ	2014-02-06
Z-1308-2014	Class II	RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software	RaySearch Laboratories AB (publ)	MUJ	2014-02-06
Z-1307-2014	Class II	RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a...	RaySearch Laboratories AB (publ)	MUJ	2014-02-06
Z-1121-2014	Class III	Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The...	Medtronic, Inc.	MAV	2014-02-06
Z-1521-2014	Class II	Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025...	Fisher Scientific Company L.L.C.	KXG	2014-02-05
Z-1214-2014	Class II	Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots...	Alere San Diego, Inc.	DJR	2014-02-05
Z-1125-2014	Class II	Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking...	Synthes GmbH	JDP	2014-02-05
Z-0971-2014	Class II	Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN #...	Boston Scientific Corporation	LIT	2014-02-04
Z-0969-2014	Class II	Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN#...	Boston Scientific Corporation	LIT	2014-02-04
Z-1144-2014	Class II	Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential...	DiaSorin Molecular LLC	OOC	2014-02-04
Z-1110-2014	Class II	Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A...	Philips North America LLC	MKJ	2014-02-04
Z-1106-2014	Class II	Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1105-2014	Class II	Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1104-2014	Class II	Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1103-2014	Class II	Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1102-2014	Class II	Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1101-2014	Class II	Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1100-2014	Class II	Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1099-2014	Class II	Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-1098-2014	Class II	Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-02-04
Z-0153-2016	Class II	OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container...	Innovative Sterilization Techn	KCT	2014-02-03