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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 745 of 1191

FDA device recalls, page 745 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2154-2013	Class II	LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2153-2013	Class II	LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2152-2013	Class II	LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2151-2013	Class II	LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2150-2013	Class II	LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2149-2013	Class II	LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2148-2013	Class II	LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-1814-2013	Class II	Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3...	Picis Clinical Solutions, Inc.	NSX	2013-06-21
Z-1933-2013	Class II	Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within...	SPINEFRONTIER, Inc. dba LESspine Innovations	FSM	2013-06-21
Z-1781-2013	Class II	Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device...	Myoscience, Inc.	GXH	2013-06-21
Z-2147-2013	Class II	LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2146-2013	Class II	LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2145-2013	Class II	LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2144-2013	Class II	LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2143-2013	Class II	LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2142-2013	Class II	LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2141-2013	Class II	LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2140-2013	Class II	LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2139-2013	Class II	LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-1743-2013	Class III	TDHistology/Cytology Classification name: Calculator/data processing module for clinical...	Technidata	JQP	2013-06-20
Z-1796-2013	Class II	TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for...	Haemonetics Corporation	JPA	2013-06-20
Z-2253-2013	Class II	GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography...	GE Healthcare	OWB	2013-06-19
Z-2094-2013	Class II	VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low...	Zimmer GmbH	KTT	2013-06-19
Z-2093-2013	Class II	VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low...	Zimmer GmbH	KTT	2013-06-19
Z-2092-2013	Class II	VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155...	Zimmer GmbH	KTT	2013-06-19
Z-2091-2013	Class II	Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75...	Zimmer GmbH	KTT	2013-06-19
Z-2088-2013	Class II	Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with...	Siemens Healthcare Diagnostics Inc.	JJE	2013-06-19
Z-0132-2014	Class II	DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and...	Eastman Kodak Company	IZL	2013-06-19
Z-2090-2013	Class II	Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150...	Zimmer GmbH	KTT	2013-06-19
Z-1617-2013	Class II	20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate...	Biosense Webster Inc	DRF	2013-06-19
Z-1749-2013	Class II	Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for...	Edwards Lifesciences LLC	DWF	2013-06-19
Z-1787-2014	Class III	Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To...	Beekley Corporation	MUE	2013-06-19
Z-1797-2013	Class II	Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J...	Philips North America LLC	MKJ	2013-06-19
Z-1806-2013	Class II	ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body...	Aesculap Inc	MAX	2013-06-18
Z-1751-2013	Class II	LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN...	Abbott Medical	FPA	2013-06-18
Z-1980-2013	Class II	CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one...	Invacare GmbH	INO	2013-06-18
Z-2736-2014	Class II	Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are...	Luminex Corporation	PEN	2013-06-17
Z-2735-2014	Class II	Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are...	Luminex Corporation	PAM	2013-06-17
Z-1835-2013	Class I	Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly...	CareFusion 303, Inc	FRN	2013-06-17
Z-1770-2013	Class I	AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1769-2013	Class I	AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1768-2013	Class I	AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1767-2013	Class I	AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1766-2013	Class I	AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1765-2013	Class I	AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1764-2013	Class I	AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1763-2013	Class I	AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1762-2013	Class I	AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1761-2013	Class I	AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1760-2013	Class I	AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17