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 851 of 1190

FDA device recalls, page 851 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2990-2011		DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat...	Sunrise Medical, Inc.	BZD	2011-03-11
Z-2601-2011		"***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS...	Leventon S. A. U.	LDR	2011-03-11
Z-2127-2011		Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded...	Carl Zeiss Meditec Inc	OBO	2011-03-10
Z-2245-2011		*REF INT411OSSEOTITE Tapered Certain Implant 4 x 11.5mm**Sterile Using...	ZimVie US Corp LLC	O-FY	2011-03-10
Z-2139-2011		*REF IOSS413* OSSEIOTITE Certain Implant 4 x 13mm* Sterile using Radiation* Rx...	ZimVie US Corp LLC	O-FY	2011-03-10
Z-2135-2011		Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East...	Zimmer GmbH	HWD	2011-03-10
Z-2126-2011		Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version...	Carl Zeiss Meditec Inc	OBO	2011-03-10
Z-1903-2011		REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3...	Zimmer GmbH	GAB	2011-03-10
Z-2059-2011		MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model...	Philips North America LLC	JAK	2011-03-10
Z-2662-2011		Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of...	Elekta Limited	IYE	2011-03-10
Z-1949-2011		Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack...	Siemens Healthcare Diagnostics Inc.	KLI	2011-03-10
Z-0347-2012		Product is labeled in part - Pouch label: "*NanoFUSEDBM**Manufactured and...	Nanotherapeutics	MQV	2011-03-10
Z-0346-2012		Product is labeled in part - Pouch label: "*ORTHOFIX*Manufactured By...	Nanotherapeutics	MQV	2011-03-10
Z-3213-2011		Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no...	Penlon, Ltd.	CCW	2011-03-10
Z-2125-2011		ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria...	Varian Medical Systems, Inc.	IYE	2011-03-09
Z-0220-2015	Class II	LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization...	Highridge Medical, LLC	MAX	2011-03-09
Z-0735-2012		R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721...	ConMed Corporation	LDD	2011-03-09
Z-0305-2012		Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant...	Elekta Limited	IYE	2011-03-09
Z-1967-2011		ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1966-2011		ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1965-2011		ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1964-2011		ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1963-2011		ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1962-2011		ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation...	Baxter Corporation Englewood	LHI	2011-03-08
Z-1748-2011		Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB...	Given Imaging Ltd.	NEZ	2011-03-08
Z-1725-2011		Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic...	Millar LLC.	DQO	2011-03-08
Z-1929-2011		GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected...	GE Healthcare	MHX	2011-03-08
Z-2207-2011		Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units...	Philips North America LLC	JAK	2011-03-07
Z-2206-2011		Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326...	Philips North America LLC	JAK	2011-03-07
Z-2205-2011		Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP...	Philips North America LLC	JAK	2011-03-07
Z-2060-2011		Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This...	Integra LifeSciences Corporation	FCW	2011-03-07
Z-1927-2011		Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San...	Stryker Corp.	HRX	2011-03-07
Z-0791-2014	Class II	Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64...	Philips North America LLC	JAK	2011-03-07
Z-3006-2011		Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx Surgical Clamps and...	Applied Medical Resources Corp	DXC	2011-03-07
Z-3005-2011		Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and...	Applied Medical Resources Corp	DXC	2011-03-07
Z-3004-2011		Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps...	Applied Medical Resources Corp	DXC	2011-03-07
Z-2663-2011		Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A...	GE Healthcare	KZD	2011-03-04
Z-1906-2011		Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and...	Penumbra Inc.	HCG	2011-03-04
Z-2137-2011		NX is the radiographer's image identification and quality control tool. It offers a broad...	AGFA Healthcare Corp.	MQB	2011-03-04
Z-1851-2011		Pelton & Crane Spirit 1800 dental chair (Model #SP18)	KaVo Dental Technologies, LLC	NRU	2011-03-04
Z-1850-2011		Pelton & Crane Spirit 3000 dental chair (Model #SP30)	KaVo Dental Technologies, LLC	NRU	2011-03-04
Z-1377-2013	Class II	*REF S-3D* 3mm Diamond Ball. Used for cutting and shaping bone.	The Anspach Effort, Inc.	HBE	2011-03-04
Z-0773-2014	Class II	Imagecast PACS is an image management system intended to be used by trained...	GE Healthcare	LLZ	2011-03-04
Z-2269-2012	Class III	Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe...	Baxter Healthcare Corporation	FRN	2011-03-04
Z-2268-2012	Class III	Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe...	Baxter Healthcare Corporation	FRN	2011-03-04
Z-2742-2011		TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for...	Haemoscope Division of Haemonetics Corp	JPA	2011-03-04
Z-2140-2011		Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V...	Zimmer GmbH	JWH	2011-03-03
Z-2104-2011		Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V...	Zimmer GmbH	JWH	2011-03-03
Z-2176-2011		Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976...	Varian Medical Systems, Inc.	IYE	2011-03-03
Z-2063-2011		Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899...	Varian Medical Systems, Inc.	IYE	2011-03-03