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 686 of 1191

FDA device recalls, page 686 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2711-2014	Class II	The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography...	Philips North America LLC	JAK	2014-09-11
Z-2731-2014	Class II	ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product...	Intuitive Surgical, Inc.	NAY	2014-09-11
Z-0951-2015	Class II	Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional...	Intertrade Imports Inc.	LPM	2014-09-10
Z-0950-2015	Class II	Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional...	Intertrade Imports Inc.	LPM	2014-09-10
Z-2737-2014	Class II	Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2...	Zimmer GmbH	GFC	2014-09-09
Z-1210-2015	Class II	Xoran MiniCAT X-ray imaging device	Xoran Technologies, LLC	JAK	2014-09-08
Z-0559-2015	Class II	Schoitz weights are manual devices used with Schoitz tonometers and are intended to...	Instrumed International Inc dba Avalign German Specialty Instruments	HKY	2014-09-08
Z-0558-2015	Class II	Tonometers are manual devices intended to measure intraocular pressure by applying a...	Instrumed International Inc dba Avalign German Specialty Instruments	HKY	2014-09-08
Z-0557-2015	Class II	Cloward Spanner gauges are bone cutting and drilling instruments that are used without a...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0556-2015	Class II	CVB distraction screws are bone cutting and drilling instruments that are used without a...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0555-2015	Class II	Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0554-2015	Class II	Traction tong replacement screws, non-springloaded are used in traction skull tongs for...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0553-2015	Class II	Titanium fixation screws, springloaded are used in traction skull tongs for traction used...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0552-2015	Class II	Lock nuts for titanium traction tongs are used in traction skull tongs for traction used...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0551-2015	Class II	Replacement screw non-springloaded traction tongs are skull tongs for traction used to...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0550-2015	Class II	Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient...	Instrumed International Inc dba Avalign German Specialty Instruments	HAX	2014-09-08
Z-0549-2015	Class II	Galt trephines are bone cutting and drilling instruments that are used without a power...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0548-2015	Class II	Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0547-2015	Class II	McKenzie enlarging burrs are bone cutting and drilling instruments that are used without...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0546-2015	Class II	D'errico perforator drills are bone cutting and drilling instruments that are used...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0545-2015	Class II	McKenzie Perforator Drills are bone cutting and drilling instruments that are used...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0544-2015	Class II	Hudson burrs are bone cutting and drilling instruments that are used without a power...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0543-2015	Class II	Cushing burrs are bone cutting and drilling instruments that are used without a power...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0542-2015	Class II	Cushing perforating drills are bone cutting and drilling instruments that are used...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0541-2015	Class II	Hudson cerebellar extensions are bone cutting and drilling instruments that are used...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0540-2015	Class II	Hudson braces are bone cutting and drilling instruments that are used without a power...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0539-2015	Class II	Manual trephines are bone cutting and drilling instruments that are used without a power...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0538-2015	Class II	A circumcision clamp is an instrument used to compress the foreskin of the penis during...	Instrumed International Inc dba Avalign German Specialty Instruments	HFX	2014-09-08
Z-0537-2015	Class II	Manual bunnell cranial drills are bone cutting and drilling instruments that are used...	Instrumed International Inc dba Avalign German Specialty Instruments	HBG	2014-09-08
Z-0536-2015	Class II	An external vein stripper is an extravascular device used to remove a section of a vein...	Instrumed International Inc dba Avalign German Specialty Instruments	MGZ	2014-09-08
Z-0535-2015	Class II	A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or...	Instrumed International Inc dba Avalign German Specialty Instruments	DRC	2014-09-08
Z-0534-2015	Class II	A zipser clamp is an instrument used to compress reduce blood flow to the penis and...	Instrumed International Inc dba Avalign German Specialty Instruments	HFX	2014-09-08
Z-0533-2015	Class II	An endometrial suction curette is a device used to remove material from the uterus and...	Instrumed International Inc dba Avalign German Specialty Instruments	HHK	2014-09-08
Z-0532-2015	Class II	A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus...	Instrumed International Inc dba Avalign German Specialty Instruments	HDC	2014-09-08
Z-0138-2015	Class III	Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of...	MEDLINE INDUSTRIES, LP - Northfield	NAD	2014-09-08
Z-0078-2015	Class II	VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-09-08
Z-0077-2015	Class II	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-09-08
Z-2714-2014	Class I	Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only...	Teleflex Medical	CAI	2014-09-08
Z-0001-2015	Class II	Philips Expression MR200 MRI Patient Monitoring System Model 866120	Invivo Corporation	MWI	2014-09-08
Z-0184-2018	Class II	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled...	Zimmer GmbH	HAW	2014-09-05
Z-0010-2015	Class II	GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D...	GE Healthcare	JAA	2014-09-05
Z-0069-2015	Class II	Philips Expression MR200 MRI Patient Monitoring System	Invivo Corporation	MWI	2014-09-05
Z-0651-2016	Class II	Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological...	Midmark Corp dba Progeny Inc	MUH	2014-09-04
Z-0453-2015	Class II	Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for...	GE Healthcare	OWB	2014-09-04
Z-0452-2015	Class II	Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating...	GE Healthcare	OWB	2014-09-04
Z-0451-2015	Class II	Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating...	GE Healthcare	IZI	2014-09-04
Z-2661-2014	Class II	Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These...	Teleflex Medical	KOD	2014-09-04
Z-0505-2015	Class II	Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070...	Teleflex Medical	OGG	2014-09-03
Z-0504-2015	Class II	Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL...	Teleflex Medical	CAF	2014-09-03
Z-2738-2014	Class II	SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled...	Baxter Healthcare Corporation	FRN	2014-09-03