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 703 of 1191

FDA device recalls, page 703 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2368-2014	Class I	ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 )...	Customed, Inc	FWZ	2014-05-20
Z-2367-2014	Class I	OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90"...	Customed, Inc	OKV	2014-05-20
Z-2366-2014	Class I	C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20"...	Customed, Inc	OHM	2014-05-20
Z-2365-2014	Class I	PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL...	Customed, Inc	OKV	2014-05-20
Z-2364-2014	Class I	LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY...	Customed, Inc	FHI	2014-05-20
Z-2363-2014	Class I	ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA...	Customed, Inc	FWZ	2014-05-20
Z-2362-2014	Class I	STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD...	Customed, Inc	LRO	2014-05-20
Z-2361-2014	Class I	CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP...	Customed, Inc	OJK	2014-05-20
Z-2360-2014	Class I	C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X...	Customed, Inc	OHM	2014-05-20
Z-2359-2014	Class I	CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1)...	Customed, Inc	OHM	2014-05-20
Z-2358-2014	Class I	PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER...	Customed, Inc	LRO	2014-05-20
Z-2357-2014	Class I	CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP...	Customed, Inc	FMH	2014-05-20
Z-2356-2014	Class I	ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12'...	Customed, Inc	FWZ	2014-05-20
Z-2355-2014	Class I	UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL &...	Customed, Inc	LRO	2014-05-20
Z-2354-2014	Class I	CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER...	Customed, Inc	OHM	2014-05-20
Z-2353-2014	Class I	LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND...	Customed, Inc	FHI	2014-05-20
Z-2352-2014	Class I	FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS...	Customed, Inc	OEQ	2014-05-20
Z-2351-2014	Class I	GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP...	Customed, Inc	LRO	2014-05-20
Z-2350-2014	Class I	NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN...	Customed, Inc	OJG	2014-05-20
Z-2349-2014	Class I	CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC...	Customed, Inc	OJH	2014-05-20
Z-2348-2014	Class I	CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT...	Customed, Inc	OJH	2014-05-20
Z-2347-2014	Class I	ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE...	Customed, Inc	OJH	2014-05-20
Z-2346-2014	Class I	IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY...	Customed, Inc	OJH	2014-05-20
Z-2345-2014	Class I	ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL...	Customed, Inc	FWZ	2014-05-20
Z-2344-2014	Class I	ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20"...	Customed, Inc	FWZ	2014-05-20
Z-2343-2014	Class I	CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1...	Customed, Inc	OHM	2014-05-20
Z-2342-2014	Class I	0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS...	Customed, Inc	OKV	2014-05-20
Z-2341-2014	Class I	PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2)...	Customed, Inc	OKV	2014-05-20
Z-2340-2014	Class I	FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO...	Customed, Inc	KKX	2014-05-20
Z-2339-2014	Class I	O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized...	Customed, Inc	KKX	2014-05-20
Z-2338-2014	Class I	ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL...	Customed, Inc	FWZ	2014-05-20
Z-2337-2014	Class I	LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T"...	Customed, Inc	FDE	2014-05-20
Z-2336-2014	Class I	ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE...	Customed, Inc	OEQ	2014-05-20
Z-2335-2014	Class I	LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH...	Customed, Inc	FDE	2014-05-20
Z-2334-2014	Class I	LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1)...	Customed, Inc	FDE	2014-05-20
Z-2333-2014	Class I	LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER...	Customed, Inc	FDE	2014-05-20
Z-2332-2014	Class I	PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS...	Customed, Inc	OKV	2014-05-20
Z-2331-2014	Class I	PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20"...	Customed, Inc	OKV	2014-05-20
Z-2330-2014	Class I	LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO...	Customed, Inc	FHI	2014-05-20
Z-2329-2014	Class I	LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77"...	Customed, Inc	FDE	2014-05-20
Z-2328-2014	Class I	LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1)...	Customed, Inc	FDE	2014-05-20
Z-2327-2014	Class I	LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5)...	Customed, Inc	FDE	2014-05-20
Z-2326-2014	Class I	MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE...	Customed, Inc	FHI	2014-05-20
Z-2325-2014	Class I	CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0)...	Customed, Inc	LRO	2014-05-20
Z-2324-2014	Class I	LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH...	Customed, Inc	OKV	2014-05-20
Z-2323-2014	Class I	LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER...	Customed, Inc	FDE	2014-05-20
Z-2322-2014	Class I	CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD...	Customed, Inc	OHM	2014-05-20
Z-2321-2014	Class I	MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1)...	Customed, Inc	PHI	2014-05-20
Z-2320-2014	Class I	CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1)...	Customed, Inc	OHM	2014-05-20
Z-2319-2014	Class I	ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER...	Customed, Inc	LRO	2014-05-20