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 , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2418-2014 | Class I | LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1... | Customed, Inc | LRO | |
| Z-2417-2014 | Class I | BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS... | Customed, Inc | LRO | |
| Z-2416-2014 | Class I | PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2)... | Customed, Inc | OKV | |
| Z-2415-2014 | Class I | HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS... | Customed, Inc | OJH | |
| Z-2414-2014 | Class I | ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN... | Customed, Inc | LRO | |
| Z-2413-2014 | Class I | LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT... | Customed, Inc | FDE | |
| Z-2412-2014 | Class I | OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL... | Customed, Inc | OJK | |
| Z-2411-2014 | Class I | UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1)... | Customed, Inc | LRO | |
| Z-2410-2014 | Class I | UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL... | Customed, Inc | LRO | |
| Z-2409-2014 | Class I | MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE... | Customed, Inc | LRO | |
| Z-2408-2014 | Class I | CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN... | Customed, Inc | OHM | |
| Z-2407-2014 | Class I | O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH... | Customed, Inc | OHD | |
| Z-2406-2014 | Class I | PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS... | Customed, Inc | OKV | |
| Z-2405-2014 | Class I | CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c... | Customed, Inc | OHM | |
| Z-2404-2014 | Class I | LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET... | Customed, Inc | FDE | |
| Z-2403-2014 | Class I | RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6"... | Customed, Inc | OJK | |
| Z-2402-2014 | Class I | UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~... | Customed, Inc | LRO | |
| Z-2401-2014 | Class I | DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING... | Customed, Inc | LRO | |
| Z-2400-2014 | Class I | UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1)... | Customed, Inc | LRO | |
| Z-2399-2014 | Class I | LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT... | Customed, Inc | LRO | |
| Z-2398-2014 | Class I | CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA... | Customed, Inc | LRO | |
| Z-2397-2014 | Class I | D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND... | Customed, Inc | FDE | |
| Z-2396-2014 | Class I | ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH... | Customed, Inc | OEQ | |
| Z-2395-2014 | Class I | E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1)... | Customed, Inc | OGR | |
| Z-2394-2014 | Class I | IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF (... | Customed, Inc | OJH | |
| Z-2393-2014 | Class I | REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I)... | Customed, Inc | LRO | |
| Z-2392-2014 | Class I | UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1)... | Customed, Inc | LRO | |
| Z-2391-2014 | Class I | PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1)... | Customed, Inc | LRO | |
| Z-2390-2014 | Class I | VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1)... | Customed, Inc | LRO | |
| Z-2389-2014 | Class I | OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5)... | Customed, Inc | OFA | |
| Z-2388-2014 | Class I | PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER... | Customed, Inc | LRO | |
| Z-2387-2014 | Class I | NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS... | Customed, Inc | OJG | |
| Z-2386-2014 | Class I | PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1)... | Customed, Inc | FWZ | |
| Z-2385-2014 | Class I | PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES... | Customed, Inc | OKV | |
| Z-2384-2014 | Class I | PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS... | Customed, Inc | FHI | |
| Z-2383-2014 | Class I | PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT... | Customed, Inc | LRO | |
| Z-2382-2014 | Class I | PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3)... | Customed, Inc | OHM | |
| Z-2381-2014 | Class I | PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE... | Customed, Inc | OJK | |
| Z-2380-2014 | Class I | OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7"... | Customed, Inc | OKV | |
| Z-2379-2014 | Class I | LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I)... | Customed, Inc | OJH | |
| Z-2378-2014 | Class I | LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T... | Customed, Inc | OHD | |
| Z-2377-2014 | Class I | LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER... | Customed, Inc | FDE | |
| Z-2376-2014 | Class I | PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2)... | Customed, Inc | LRO | |
| Z-2375-2014 | Class I | NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT... | Customed, Inc | OJG | |
| Z-2374-2014 | Class I | FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID... | Customed, Inc | NWR | |
| Z-2373-2014 | Class I | FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK... | Customed, Inc | NWR | |
| Z-2372-2014 | Class I | PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20"... | Customed, Inc | OKV | |
| Z-2371-2014 | Class I | ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd... | Customed, Inc | FWZ | |
| Z-2370-2014 | Class I | PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP... | Customed, Inc | OKV | |
| Z-2369-2014 | Class I | LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20"... | Customed, Inc | FDE |
