FDA recalls, November 2016: 312 published

104 different companies appear this month.

Risk classification: Class I: 66 · Class II: 202 · Class III: 44

Same month, other agencies:CPSC 27 recallsFSIS 15 recallsNHTSA 73 recalls

Recalls this month

DateProduct
November 23, 2016OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Tr…Z-0509-2017ICU Medical, Inc.
November 23, 2016SAUER'S HOT CHILl POWDER, 2.25oz.F-0446-2017C.F. Sauer Company
November 23, 2016QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 4609…Z-0513-2017ICU Medical, Inc.
November 23, 2016Baptista Bakery & Pastry Inc. Italian Bread, 16 oz. plasticF-0472-2017Batista Bakery & Pastries, Inc.
November 23, 2016TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (P…Z-0443-2017ICU Medical, Inc.
November 23, 2016CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DS…Z-0519-2017ICU Medical, Inc.
November 23, 2016SAUER'S CHILl POWDER, 2.25 oz.F-0445-2017C.F. Sauer Company
November 23, 2016Vanilla Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28614 1.F-0459-2017Nobel Bakery
November 23, 2016L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC…D-0141-2017Sandoz Inc
November 23, 2016Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, …Z-0554-2017ICU Medical, Inc.
November 23, 2016TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (…Z-0440-2017ICU Medical, Inc.
November 23, 2016Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Contro…Z-0570-2017ICU Medical, Inc.
November 23, 2016BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac D…Z-0510-2017ICU Medical, Inc.
November 23, 2016KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Str…Z-0462-2017ICU Medical, Inc.
November 23, 2016Hot Pepper Cheese, forty-five 40 lb. blocksF-0431-2017Farm Country Cheese House, Inc.
November 23, 2016L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (…D-0140-2017Sandoz Inc
November 23, 2016Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and…Z-0516-2017ICU Medical, Inc.
November 23, 2016SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definitio…Z-0605-2017Siemens Medical Solutions USA, Inc
November 23, 2016ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Cent…Z-0613-2017Siemens Healthcare Diagnostics, Inc
November 23, 2016MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transp…Z-0482-2017ICU Medical, Inc.
November 23, 2016SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition…Z-0607-2017Siemens Medical Solutions USA, Inc
November 23, 2016TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item…Z-0526-2017ICU Medical, Inc.
November 23, 2016Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (…D-0137-2017Amerisource Health Services
November 23, 2016MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpa…Z-0459-2017ICU Medical, Inc.
November 23, 2016Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plasticF-0471-2017Batista Bakery & Pastries, Inc.
November 23, 2016FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufac…D-0139-2017CutisPharma, Inc.
November 23, 2016Frozen Onion Rings sold and distributed under the following private label retail brands: …F-0433-2017McCain Foods USA
November 23, 2016Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Ma…D-0142-2017GSK Consumer Healthcare
November 23, 2016TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item N…Z-0417-2017ICU Medical, Inc.
November 23, 2016TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP…Z-0441-2017ICU Medical, Inc.
November 23, 2016ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac …Z-0458-2017ICU Medical, Inc.
November 23, 2016Apricot Perouk, Net Wt. 10 oz. (283g), UPC 7 80890 28601 1.F-0462-2017Nobel Bakery
November 23, 2016CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight…Z-0499-2017ICU Medical, Inc.
November 23, 2016MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Di…Z-0512-2017ICU Medical, Inc.
November 23, 2016TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposa…Z-0525-2017ICU Medical, Inc.
November 23, 2016Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV a…Z-0541-2017ICU Medical, Inc.
November 23, 2016TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE…Z-0434-2017ICU Medical, Inc.
November 23, 2016Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" R…Z-0560-2017ICU Medical, Inc.
November 23, 2016MEVION S250 Product Usage: Proton Radiation TherapyZ-0409-2017Mevion Medical Systems, Inc.
November 23, 2016Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifo…Z-0491-2017ICU Medical, Inc.
November 23, 2016CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Tr…Z-0574-2017ICU Medical, Inc.
November 16, 2016Refrigerated, Ready to Eat Holland Herring in Oil under firms brand name FRESH SEAFOOD pa…F-0409-2017Royal Seafood Baza
November 16, 2016Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy NetworkD-0127-2017Wells Pharmacy Network, LLC
November 16, 2016Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plas…F-0389-2017Royal Seafood Baza
November 16, 2016Iberia Codfish Fritter MixF-0347-2017Productos La Finca, Inc.
November 16, 2016Muscle Milk Caf¿ Latte Caf¿ Latte, 414 mL UPC (case): 8-76063-00215-8; UPC (uni…F-0335-2017H.P. Hood, LLC
November 16, 2016Market Basket Plain Sub (Grinder) rolls-F-0291-2017Koffee Kup Bakery Inc.
November 16, 2016Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged…F-0386-2017Royal Seafood Baza
November 16, 2016Trader Joe's Chocolate Orange Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UP…F-0312-2017Trader Joes Company
November 16, 2016Refrigerated, ready-to-eat marinated apples packaged in 15 Lb. bulk white plastic bucket …F-0395-2017Royal Seafood Baza

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