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-2468-2014 | Class I | LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO... | Customed, Inc | FDE | |
| Z-2467-2014 | Class I | LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF... | Customed, Inc | FDE | |
| Z-2466-2014 | Class I | LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL... | Customed, Inc | FDE | |
| Z-2465-2014 | Class I | CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2)... | Customed, Inc | KKK | |
| Z-2464-2014 | Class I | MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1)... | Customed, Inc | OJH | |
| Z-2463-2014 | Class I | C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF... | Customed, Inc | OKV | |
| Z-2462-2014 | Class I | ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN... | Customed, Inc | LRO | |
| Z-2461-2014 | Class I | BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE... | Customed, Inc | LRO | |
| Z-2460-2014 | Class I | BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN... | Customed, Inc | LRO | |
| Z-2459-2014 | Class I | 08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID... | Customed, Inc | OKV | |
| Z-2458-2014 | Class I | KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1)... | Customed, Inc | OJH | |
| Z-2457-2014 | Class I | CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE... | Customed, Inc | LRO | |
| Z-2456-2014 | Class I | EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN... | Customed, Inc | LRO | |
| Z-2455-2014 | Class I | EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l... | Customed, Inc | OGR | |
| Z-2454-2014 | Class I | TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II... | Customed, Inc | OJF | |
| Z-2453-2014 | Class I | VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS... | Customed, Inc | LRO | |
| Z-2452-2014 | Class I | ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1)... | Customed, Inc | OJH | |
| Z-2451-2014 | Class I | FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6"... | Customed, Inc | LRO | |
| Z-2450-2014 | Class I | LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) *... | Customed, Inc | LRO | |
| Z-2449-2014 | Class I | CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED... | Customed, Inc | LRO | |
| Z-2448-2014 | Class I | LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED... | Customed, Inc | OJH | |
| Z-2447-2014 | Class I | LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE... | Customed, Inc | FDE | |
| Z-2446-2014 | Class I | CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL... | Customed, Inc | LRO | |
| Z-2445-2014 | Class I | LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml... | Customed, Inc | FDE | |
| Z-2444-2014 | Class I | LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE... | Customed, Inc | FDE | |
| Z-2443-2014 | Class I | NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X... | Customed, Inc | OJG | |
| Z-2442-2014 | Class I | EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN... | Customed, Inc | OGR | |
| Z-2441-2014 | Class I | SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY... | Customed, Inc | LRO | |
| Z-2440-2014 | Class I | LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1... | Customed, Inc | FDE | |
| Z-2439-2014 | Class I | SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2)... | Customed, Inc | OJH | |
| Z-2438-2014 | Class I | HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV... | Customed, Inc | LRO | |
| Z-2437-2014 | Class I | LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7'' CUFF 30" X... | Customed, Inc | LRO | |
| Z-2436-2014 | Class I | FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57"... | Customed, Inc | OJH | |
| Z-2435-2014 | Class I | KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE... | Customed, Inc | FWZ | |
| Z-2434-2014 | Class I | NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC... | Customed, Inc | OJG | |
| Z-2433-2014 | Class I | OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF... | Customed, Inc | OFA | |
| Z-2432-2014 | Class I | ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER... | Customed, Inc | OJH | |
| Z-2431-2014 | Class I | ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x... | Customed, Inc | OEQ | |
| Z-2430-2014 | Class I | CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2)... | Customed, Inc | OHM | |
| Z-2429-2014 | Class I | LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER... | Customed, Inc | FDE | |
| Z-2428-2014 | Class I | GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER... | Customed, Inc | LRO | |
| Z-2427-2014 | Class I | O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2)... | Customed, Inc | OKV | |
| Z-2426-2014 | Class I | SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER... | Customed, Inc | OJH | |
| Z-2425-2014 | Class I | TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED... | Customed, Inc | LRO | |
| Z-2424-2014 | Class I | LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES... | Customed, Inc | FDE | |
| Z-2423-2014 | Class I | HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT... | Customed, Inc | LRO | |
| Z-2422-2014 | Class I | ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr... | Customed, Inc | LRO | |
| Z-2421-2014 | Class I | UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE... | Customed, Inc | LRO | |
| Z-2420-2014 | Class I | OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL... | Customed, Inc | OJK | |
| Z-2419-2014 | Class I | AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED... | Customed, Inc | LRO |
