FDA recalls, September 2014: 547 published

132 different companies appear this month.

Risk classification: Class I: 319 · Class II: 216 · Class III: 12

Same month, other agencies:FSIS 8 recallsNHTSA 96 recalls

Recalls this month

DateProduct
September 10, 2014Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE S…Z-2495-2014Customed, Inc
September 10, 2014E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1)…Z-2395-2014Customed, Inc
September 10, 2014SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILIT…Z-2441-2014Customed, Inc
September 10, 2014PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF…Z-2358-2014Customed, Inc
September 10, 2014Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and…Z-2564-2014Hitachi Medical Systems America Inc
September 10, 2014Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 …Z-2514-2014Customed, Inc
September 10, 2014MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LAR…Z-2409-2014Customed, Inc
September 10, 2014Brown carob powder packed in a plastic heat sealed 16oz. bag, labeled in part "Live Super…F-2410-2014Live Superfoods
September 10, 2014ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (…Z-2473-2014Customed, Inc
September 10, 201408 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID…Z-2459-2014Customed, Inc
September 10, 2014Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill …Z-2519-2014Customed, Inc
September 10, 2014TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED …Z-2425-2014Customed, Inc
September 10, 2014CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. …Z-2343-2014Customed, Inc
September 10, 2014PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONG…Z-2385-2014Customed, Inc
September 10, 2014GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFO…Z-2428-2014Customed, Inc
September 10, 2014PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2)…Z-2341-2014Customed, Inc
September 10, 2014Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL …Z-2477-2014Customed, Inc
September 10, 2014FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO ster…Z-2340-2014Customed, Inc
September 10, 2014gomacro MACROBAR brand almond butter + carob. Net Wt. 2 oz (57 g)F-2405-2014GoMacro, Inc.
September 10, 2014LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL D…Z-2533-2014Customed, Inc
September 10, 2014Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO …Z-2482-2014Customed, Inc
September 10, 2014Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751…Z-2566-2014Biomet Microfixation, LLC
September 10, 2014VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF …Z-2390-2014Customed, Inc
September 10, 2014O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LE…Z-2427-2014Customed, Inc
September 10, 2014EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVE…Z-2471-2014Customed, Inc
September 10, 2014Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00…Z-2585-2014Zimmer, Inc.
September 10, 2014OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured fo…D-1572-2014Qualitest Pharmaceuticals
September 10, 2014MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16)…Z-2503-2014Customed, Inc
September 10, 2014ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" …Z-2313-2014Customed, Inc
September 10, 2014Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCE…Z-2518-2014Customed, Inc
September 10, 2014LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY…Z-2364-2014Customed, Inc
September 10, 2014Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAM…Z-2521-2014Customed, Inc
September 10, 2014MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1)…Z-2321-2014Customed, Inc
September 10, 2014Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., …Z-2307-2014Customed, Inc
September 10, 2014TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPRE…Z-2512-2014Customed, Inc
September 10, 2014Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured b…D-1576-2014Apotex Inc.
September 10, 2014REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF (…Z-2393-2014Customed, Inc
September 10, 2014Choripdong Chocolate Almond Richmond Ice Bar 4 bars/432 mL Seoul Trading USA Inc., Englew…F-2416-2014Seoul Shik Poom, Inc.
September 10, 2014LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH…Z-2324-2014Customed, Inc
September 10, 2014FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57…Z-2436-2014Customed, Inc
September 10, 2014BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE U…Z-2461-2014Customed, Inc
September 10, 2014ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient m…Z-2586-2014Spacelabs Healthcare Inc
September 10, 2014Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-0…Z-2582-2014Zimmer, Inc.
September 10, 2014GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY U…Z-2589-2014Galt Medical Corporation
September 10, 2014PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWE…Z-2406-2014Customed, Inc
September 10, 2014NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30"…Z-2443-2014Customed, Inc
September 10, 2014FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WO…Z-2451-2014Customed, Inc
September 10, 2014Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT …Z-2492-2014Customed, Inc
September 10, 2014OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) T…Z-2412-2014Customed, Inc
September 10, 2014BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH T…Z-2317-2014Customed, Inc

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