FDA recalls, June 2017: 395 published

91 different companies appear this month.

Risk classification: Class I: 30 · Class II: 346 · Class III: 19

Same month, other agencies:CPSC 19 recallsFSIS 25 recallsNHTSA 62 recalls

Recalls this month

DateProduct
June 21, 2017GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray systemZ-2194-2017GE Healthcare, LLC
June 21, 2017VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per cart…Z-2372-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.Z-2385-2017Biomerieux Inc
June 21, 2017USPACK-SUTURE KIT; Item Number: US1672Z-2546-2017Medtronic
June 21, 2017VITEK¿ 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards per cart…Z-2475-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per cart…Z-2503-2017Biomerieux Inc
June 21, 2017Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS…Z-2332-2017Arrow International Inc
June 21, 2017VITEK¿ 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards per cart…Z-2484-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per cart…Z-2491-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per cart…Z-2469-2017Biomerieux Inc
June 21, 2017Infant Warmer System (IWS)Z-2323-2017GE Healthcare, LLC
June 21, 2017Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5…Z-2542-2017Medtronic
June 21, 2017GE Healthcare BrightSpeed X-ray systemZ-2188-2017GE Healthcare, LLC
June 21, 2017VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per cart…Z-2483-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton.Z-2419-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton.Z-2464-2017Biomerieux Inc
June 21, 2017VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per car…Z-2521-2017Biomerieux Inc
June 21, 2017AAHU BARAH, DRY FIG, NET WT. 1 LB, PRODUCT OF PAKISTANF-2371-2017GLOBAL COMMODITIES INC
June 21, 2017VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.Z-2461-2017Biomerieux Inc
June 21, 2017Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83m…Z-2531-2017Creganna Medical Devices
June 14, 2017Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Cath…Z-2260-2017Arrow International Inc
June 14, 2017AUNT JEMIMA(R) 14 BLUEBERRY WAFFLES, NET WT 17.18oz UPC 019600062202F-2305-2017Pinnacle Foods, LLC
June 14, 2017Fettuccine Gluten Free. Product is made refrigerated. Product is packaged in plastic c…F-2340-2017Alaska Pasta Company
June 14, 2017AUNT JEMIMA(R) 14 HOMESTYLE WAFFLES, NET WT 17.18oz UPC 019600062004F-2303-2017Pinnacle Foods, LLC
June 14, 2017Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiatio…Z-2221-2017Acumedia Manufacturers, Inc.
June 14, 2017Waffles packaged as follows: a) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC …F-2313-2017Pinnacle Foods, LLC
June 14, 2017ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infus…Z-2308-2017Arrow International Inc
June 14, 2017High Liner Foods, Breaded Haddock Tail Portions 5 oz.F-2270-2017ISF "USA", LLC
June 14, 2017ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infus…Z-2307-2017Arrow International Inc
June 14, 2017ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venou…Z-2264-2017Arrow International Inc
June 14, 2017AUNT JEMIMA(R) MiNi pancakes, BLUEBERRY BLAST, NET WT 3.2 OZ, UPC 001960043567F-2308-2017Pinnacle Foods, LLC
June 14, 2017AUNT JEMIMA(R) FRENCH TOAST MADE WITH WHOLE GRAIN, 6 COUNT, NET WT 12.5oz, UPC 019600059…F-2302-2017Pinnacle Foods, LLC
June 14, 2017Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2…Z-2242-2017ConvaTec, Inc
June 14, 2017A&W, GIN 0040995 Raw Breaded Fish Portions 3.5 ozF-2275-2017ISF "USA", LLC
June 14, 2017ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. C…Z-2254-2017Arrow International Inc
June 14, 2017Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) C…Z-2258-2017Arrow International Inc
June 14, 2017Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Che…Z-2237-2017ConvaTec, Inc
June 14, 2017Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, a…D-0894-2017Qualgen
June 14, 2017Lasagne Sheets Spinach. Product is made refrigerated. Product is packaged in plastic c…F-2343-2017Alaska Pasta Company
June 14, 2017Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count b…D-0891-2017Qualgen
June 14, 2017Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) …Z-2321-2017OrthoPediatrics Corp
June 14, 2017Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, …Z-2220-2017Iba Dosimetry
June 14, 2017Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Insert…Z-2287-2017Arrow International Inc
June 14, 2017Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, an…D-0889-2017Qualgen
June 14, 2017Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, an…D-0890-2017Qualgen
June 14, 2017KRISPPE FAMOUS RHODE ISLAND CLAM CAKE MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs.F-2332-2017Krisppee Products Co.
June 14, 2017KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.Z-2247-2017Medtronic Sofamor Danek USA Inc
June 14, 2017Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per ca…D-0884-2017Dr. Reddy's Laboratories, Inc.
June 14, 2017Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharm…D-0897-2017Hetero USA Inc
June 14, 2017Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Insert…Z-2289-2017Arrow International Inc

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