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 708 of 1191

FDA device recalls, page 708 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1554-2014	Class II	Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.	Bausch & Lomb Incorporated	LYL	2014-04-21
Z-1676-2014	Class II	Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The...	Aesculap Inc	JXG	2014-04-21
Z-1577-2014	Class II	Recalled product is a component of the Newport Medical Instruments e360 Ventilator...	Medtronic, Inc.	CBK	2014-04-18
Z-0179-2015	Class II	Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue...	Leica Microsystems, Inc.	NJT	2014-04-18
Z-1543-2014	Class II	RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 "...	Med-Mizer, Inc.	FNK	2014-04-18
Z-1542-2014	Class II	RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe...	Med-Mizer, Inc.	FNK	2014-04-18
Z-1541-2014	Class II	RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2...	Med-Mizer, Inc.	FNL	2014-04-18
Z-0419-2016	Class II	Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult...	Teleflex Medical	BTT	2014-04-17
Z-1536-2015	Class II	The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single...	Baxter Healthcare Corporation	MEA	2014-04-17
Z-1741-2014	Class II	enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-04-17
Z-1793-2014	Class III	APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and...	Hologic, Inc.	OIE	2014-04-17
Z-1617-2014	Class II	McKesson Radiology-PACS. McKesson Radiology is a medical image and information...	Change Healthcare Canada Company	LLZ	2014-04-17
Z-2170-2014	Class II	Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the...	Luminex Corporation	PEN	2014-04-17
Z-1514-2014	Class II	HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation...	Elekta Limited	JAI	2014-04-17
Z-1675-2014	Class II	Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2...	Integra LifeSciences Corporation	GWM	2014-04-16
Z-1730-2014	Class II	Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or...	Maquet Cardiovascular Us Sales, LLC	FSY	2014-04-16
Z-1748-2014	Class II	Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use...	Sakura Finetek USA Inc	KEO	2014-04-16
Z-2148-2014	Class I	DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC...	Synthes GmbH	MQN	2014-04-16
Z-1544-2014	Class II	12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold...	Stryker Corp.	GEI	2014-04-16
Z-1546-2014	Class I	Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2...	Alere San Diego, Inc.	GJS	2014-04-16
Z-1620-2014	Class II	RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200...	Baxter Corporation Englewood	FMF	2014-04-16
Z-1644-2014	Class II	Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products...	Gambro Renal Products	KDI	2014-04-16
Z-1643-2014	Class II	Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc...	Gambro Renal Products	KDI	2014-04-16
Z-1607-2014	Class II	HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare...	HeartWare, Inc.	DSQ	2014-04-16
Z-0303-2017	Class II	ReTurn 7500/7500 Aid, transfer	Handicare USA, Inc.	IKX	2014-04-15
Z-2405-2015	Class II	RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years)...	Cordis US Corp.	MPB	2014-04-15
Z-1803-2014	Class II	EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a...	Zimmer GmbH	HWQ	2014-04-15
Z-1802-2014	Class II	EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical...	Zimmer GmbH	LXH	2014-04-15
Z-1801-2014	Class II	EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual...	Zimmer GmbH	LXH	2014-04-15
Z-1539-2014	Class I	Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10...	Fisher & Paykel Healthcare, Inc.	BZO	2014-04-15
Z-1707-2014	Class II	ExacTrac 5.5, an Image Processing System used for patient positioning for radiation...	Brainlab, Inc.	IYE	2014-04-15
Z-1733-2014	Class II	Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement...	Siemens Healthcare Diagnostics Inc.	JJE	2014-04-14
Z-1552-2014	Class II	TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip...	Tenex Health	LFL	2014-04-14
Z-1713-2014	Class II	Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYB	2014-04-14
Z-2030-2014	Class II	Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without...	Terumo Cardiovascular Systems Corporation	KFM	2014-04-14
Z-1486-2014	Class II	Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft...	Merit Medical Systems, Inc.	DQX	2014-04-14
Z-1485-2014	Class II	Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff...	Merit Medical Systems, Inc.	DQX	2014-04-14
Z-2029-2014	Class II	Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use...	Terumo Cardiovascular Systems Corporation	KFM	2014-04-14
Z-2028-2014	Class II	Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use...	Terumo Cardiovascular Systems Corporation	KFM	2014-04-14
Z-1635-2014	Class II	Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number...	Microline Surgical, Inc	GEI	2014-04-14
Z-1740-2014	Class II	bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin...	Ivoclar Vivadent, Inc.	EBZ	2014-04-14
Z-1616-2014	Class II	ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count...	Roche Diagnostics GmbH	NBW	2014-04-14
Z-1711-2014	Class II	AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal...	Siemens Medical Solutions USA, Inc.	OWB	2014-04-11
Z-1575-2014	Class II	NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010...	Blue Belt Technologies MN	OLO	2014-04-11
Z-1736-2014	Class II	VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-04-10
Z-1735-2014	Class II	VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-04-10
Z-1734-2014	Class II	VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-04-10
Z-1738-2014	Class II	enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-04-10
Z-1833-2014	Class II	Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance...	Synthes GmbH	KTT	2014-04-10
Z-1641-2014	Class I	Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is...	Abbott Medical	BTR	2014-04-10