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 704 of 1191

FDA device recalls, page 704 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2318-2014	Class I	OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED...	Customed, Inc	OJK	2014-05-20
Z-2317-2014	Class I	BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH...	Customed, Inc	LRO	2014-05-20
Z-2316-2014	Class I	LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I)...	Customed, Inc	FHI	2014-05-20
Z-2315-2014	Class I	LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY...	Customed, Inc	FHI	2014-05-20
Z-2314-2014	Class I	0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2)...	Customed, Inc	OKV	2014-05-20
Z-2313-2014	Class I	ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90"...	Customed, Inc	OEQ	2014-05-20
Z-2312-2014	Class I	LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO...	Customed, Inc	FHI	2014-05-20
Z-2311-2014	Class I	OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO...	Customed, Inc	OFA	2014-05-20
Z-2310-2014	Class I	Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X...	Customed, Inc	OKV	2014-05-20
Z-2309-2014	Class I	Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS...	Customed, Inc	OKV	2014-05-20
Z-2308-2014	Class I	Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc...	Customed, Inc	LRO	2014-05-20
Z-2307-2014	Class I	Customed Laparotomy Pack , convenience pack include multiple components: drape laparot...	Customed, Inc	FHI	2014-05-20
Z-2306-2014	Class I	Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff...	Customed, Inc	LRO	2014-05-20
Z-2305-2014	Class I	Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand...	Customed, Inc	FHI	2014-05-20
Z-2304-2014	Class I	Customed Laparoscopy convenience pack include multiple components: gowns, table covers...	Customed, Inc	FDE	2014-05-20
Z-2303-2014	Class I	Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent...	Customed, Inc	OKV	2014-05-20
Z-2302-2014	Class I	Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and...	Customed, Inc	OEQ	2014-05-20
Z-1944-2014	Class II	syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.	Siemens Healthcare Diagnostics Inc.	JQP	2014-05-20
Z-2059-2014	Class II	V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for...	Datascope Corp.	MHX	2014-05-19
Z-1939-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1938-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1937-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1936-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1935-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1934-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1933-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1932-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-1931-2014	Class II	NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component...	Zimmer GmbH	JWH	2014-05-19
Z-2127-2014	Class II	Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets...	Small Bone Innovations, Inc.	HWC	2014-05-19
Z-1872-2014	Class II	Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of...	Stryker Corp.	HRX	2014-05-19
Z-1842-2014	Class II	VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581	Zimmer GmbH	LPH	2014-05-19
Z-1868-2014	Class II	Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot...	Integra LifeSciences Corporation	MBP	2014-05-19
Z-2717-2014	Class II	CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50	KCI USA, Inc.	GFD	2014-05-19
Z-1947-2014	Class II	Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006...	Alcon Laboratories	LRO	2014-05-16
Z-1786-2014	Class II	Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the...	Teleflex Medical	GBZ	2014-05-16
Z-2120-2014	Class II	GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model...	Nidek Incorporated	GEX	2014-05-16
Z-1948-2014	Class I	Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000...	Salter Labs	BTM	2014-05-16
Z-2121-2017	Class III	Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white...	Horiba Instruments Incorporated	JJY	2014-05-15
Z-1811-2014	Class II	Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal...	Ebi, LLC	HXX	2014-05-15
Z-1827-2014	Class II	Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T...	Philips North America LLC	LNH	2014-05-15
Z-1826-2014	Class II	Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T...	Philips North America LLC	LNH	2014-05-15
Z-1925-2014	Class II	DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V...	Zimmer GmbH	JDC	2014-05-15
Z-2075-2014	Class II	Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite...	Siemens Medical Solutions USA, Inc.	MUJ	2014-05-15
Z-1984-2014	Class II	Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part...	Synthes GmbH	HWC	2014-05-15
Z-1799-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric...	Boston Scientific Corporation	OAD	2014-05-15
Z-1798-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC...	Boston Scientific Corporation	OAD	2014-05-15
Z-1797-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The...	Boston Scientific Corporation	OAD	2014-05-15
Z-1796-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric...	Boston Scientific Corporation	OAD	2014-05-15
Z-1795-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The...	Boston Scientific Corporation	OAD	2014-05-15
Z-1794-2014	Class II	IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The...	Boston Scientific Corporation	OAD	2014-05-15