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High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Medical Devices·1,250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Medical Devices·630 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Surgical Devices·50 affected·Aug 13, 2018
High RiskFDA
Remel Inc
remel THIOGLYCOLLATE MEDIUM, REF 05152
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Medical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Medical Devices·30 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Medical Devices·250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number...
Medical Devices·1 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Medical Devices·80 affected·Aug 13, 2018
High RiskFDA
The Binding Site Group, Ltd.
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage:...
Diagnostic Devices·462 affected·Aug 12, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Ophthalmic Drugs·7 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 1570...
Oral Drugs·21 affected·Aug 10, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1c...
Drugs·222 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 1570...
Oral Drugs·36 affected·Aug 10, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Injectable Drugs·80 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701...
Oral Drugs·9 affected·Aug 10, 2018
High RiskFDA
A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 L...
Respiratory Devices·610 affected·Aug 10, 2018
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vas...
Surgical Devices·67 affected·Aug 10, 2018
High RiskFDA
Deli Star Ventures Inc. Dba King's Food Products
Chef s Request professional steak marinade and Buckhead wildlife marinade, 12oz, 64oz, 1 gallon; shelf stable, refrigerate after opening
Food·4,715 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: Th...
Medical Devices·10 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: Th...
Medical Devices·6 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: Th...
Medical Devices·1 affected·Aug 9, 2018
High RiskFDA
Besmed Health Business Corporation
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Medical Devices·267 affected·Aug 9, 2018
High RiskFDA
Morgan Foods, Inc.
Tomato Condensed Soup, 26 oz (1 LB 10 OZ) 737 g, 307 x 512 Can, Family Size, 12 cans per tray, shelf stable
Produce·6,168 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscata...
Oral Drugs·441,408 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscatawa...
Oral Drugs·316,380 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataw...
Oral Drugs·441,408 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Pi...
Oral Drugs·394,896 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Medical Devices·10 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-XP160F
Medical Devices·1,461 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
Medical Devices·16 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Medical Devices·18 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Medical Devices·34 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Medical Devices·14 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Medical Devices·29 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Medical Devices·68 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Rhino Laryngo scope ENF-VT2
Medical Devices·3,701 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-240
Medical Devices·1,467 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Medical Devices·38 affected·Aug 8, 2018
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris El...
Medical Devices·9 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Ultrasonic Bronchoscope BF-UC160F-OL8
Medical Devices·879 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchofiberscope F-1T160
Medical Devices·3,317 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope F-1TQ180
Medical Devices·1,134 affected·Aug 8, 2018
High RiskFDA
Olympus Corporation Of The Americas
Bronchovideoscope BF-P240
Medical Devices·2,163 affected·Aug 8, 2018