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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 679 of 1191

FDA device recalls, page 679 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0185-2015	Class II	GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC...	GE Healthcare	KPS	2014-10-14
Z-0184-2015	Class II	GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II...	GE Healthcare	KPS	2014-10-14
Z-0177-2015	Class II	St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353	Abbott Medical	DRF	2014-10-14
Z-0108-2015	Class II	St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile...	Abbott Medical	DYB	2014-10-14
Z-0424-2015	Class II	Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor...	Zimmer GmbH	HWA	2014-10-14
Z-0423-2015	Class II	Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in...	Zimmer GmbH	HWA	2014-10-14
Z-0205-2015	Class II	Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K	Medtronic, Inc.	DQY	2014-10-13
Z-1277-2015	Class II	Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set...	US Infusion LLC. D/B/a Truecare Biomedix-USA	FPA	2014-10-10
Z-0235-2015	Class II	Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage...	Siemens Medical Solutions USA, Inc.	KPQ	2014-10-10
Z-0206-2015	Class I	Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2...	Philips North America LLC	FMP	2014-10-10
Z-0209-2015	Class II	AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit)...	American Medical Systems, Inc.	JCW	2014-10-10
Z-0216-2015	Class II	Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This...	Silver Star Brands Inc	IOR	2014-10-10
Z-0196-2015	Class II	The 5085 is a general surgical table with high patient weight capacity, extended width...	STERIS Corporation	GDC	2014-10-10
Z-0572-2015	Class II	BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a...	Becton Dickinson & Co	FOZ	2014-10-09
Z-0860-2015	Class II	ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a...	Siemens Healthcare Diagnostics Inc.	JJE	2014-10-09
Z-0859-2015	Class II	ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro...	Siemens Healthcare Diagnostics Inc.	JJE	2014-10-09
Z-0190-2015	Class II	MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a...	Philips North America LLC	JAK	2014-10-09
Z-0906-2015	Class II	Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog...	Exactech, Inc.	JWH	2014-10-09
Z-0169-2015	Class II	Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System	Cynosure, LLC	GEX	2014-10-09
Z-0141-2015	Class II	TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia...	Hill-Rom Inc.	JEA	2014-10-09
Z-0198-2015	Class II	Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for...	Zimmer GmbH	JWH	2014-10-09
Z-0909-2015	Class II	Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and...	Ebi, LLC	NKB	2014-10-08
Z-0415-2015	Class I	C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care...	Customed, Inc	OHM	2014-10-08
Z-0414-2015	Class I	Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care...	Customed, Inc	OKV	2014-10-08
Z-0413-2015	Class I	Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care...	Customed, Inc	LRO	2014-10-08
Z-0412-2015	Class I	Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care...	Customed, Inc	FWZ	2014-10-08
Z-0411-2015	Class I	Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perform patient...	Customed, Inc	LRO	2014-10-08
Z-0410-2015	Class I	Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care...	Customed, Inc	OJK	2014-10-08
Z-0409-2015	Class I	C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient...	Customed, Inc	OHM	2014-10-08
Z-0408-2015	Class I	Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care...	Customed, Inc	LRO	2014-10-08
Z-0407-2015	Class I	, Catalog # 900-913 Used by medical staff to perform patient care procedures such as...	Customed, Inc	FMH	2014-10-08
Z-0406-2015	Class I	Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care...	Customed, Inc	FWZ	2014-10-08
Z-0405-2015	Class I	Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures...	Customed, Inc	LRO	2014-10-08
Z-0404-2015	Class I	Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient care...	Customed, Inc	OHM	2014-10-08
Z-0403-2015	Class I	Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care...	Customed, Inc	LRO	2014-10-08
Z-0402-2015	Class I	Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform...	Customed, Inc	OEQ	2014-10-08
Z-0401-2015	Class I	General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care...	Customed, Inc	LRO	2014-10-08
Z-0400-2015	Class I	Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures...	Customed, Inc	OJG	2014-10-08
Z-0399-2015	Class I	Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform...	Customed, Inc	OJH	2014-10-08
Z-0398-2015	Class I	Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient...	Customed, Inc	FWZ	2014-10-08
Z-0397-2015	Class I	Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care...	Customed, Inc	OHM	2014-10-08
Z-0396-2015	Class I	O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care...	Customed, Inc	OKV	2014-10-08
Z-0395-2015	Class I	Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care...	Customed, Inc	OKV	2014-10-08
Z-0394-2015	Class I	Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care...	Customed, Inc	KKX	2014-10-08
Z-0393-2015	Class I	O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care...	Customed, Inc	KKX	2014-10-08
Z-0392-2015	Class I	Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care...	Customed, Inc	FWZ	2014-10-08
Z-0391-2015	Class I	Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care...	Customed, Inc	OEQ	2014-10-08
Z-0390-2015	Class I	Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient...	Customed, Inc	FDE	2014-10-08
Z-0389-2015	Class I	Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical...	Customed, Inc	FDE	2014-10-08
Z-0388-2015	Class I	Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform...	Customed, Inc	OKV	2014-10-08