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High RiskFDA
Medtronic
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Cook Inc.
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the...
Medical Devices·10,415 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 17...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
USPACK-SUTURE KIT; Item Number: US1672
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON*...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Medtronic
Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECU...
Medical Devices·478,465 affected·May 3, 2017
High RiskFDA
Fuji Natural Foods, Inc.
Bean Sprout 10 lbs. bag, 10lb box, 12/12oz, 20/15oz, 24/1.5 lbs., 5lbs. bag, 3lb tray
Food·6,978 affected·May 2, 2017
High RiskFDA
Ge Healthcare, Llc
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Medical Devices·3,448 affected·May 2, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Medical Devices·151 affected·May 2, 2017
High RiskFDA
Allergan Sales, Llc
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured b...
Topical Drugs·648 affected·May 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instr...
Surgical Devices·16 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabil...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Toshiba American Medical Systems Inc
XARIO 200 TUS-X200 diagnostic ultrasound system
Diagnostic Devices·1 affected·May 1, 2017
High RiskFDA
Toshiba American Medical Systems Inc
APLIO 500 TUS-A500 diagnostic ultrasound system
Diagnostic Devices·307 affected·May 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of ins...
Surgical Devices·1 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stab...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Unisea Inc.
Frozen Wild Shrimp Burgers, Wild Grill Foods brand, net wt. 12 oz. Each package contains 4/ 3 oz. pieces. UPC 8 94067 00248 6. The 12...
Dairy·208 affected·Apr 28, 2017
High RiskFDA
Par Sterile Products Llc
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC ...
Injectable Drugs·122,469 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32...
Medical Devices·24,969 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Medical Devices·445 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNI...
Medical Devices·1,707 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 14...
Medical Devices·510 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MM...
Medical Devices·27,279 affected·Apr 28, 2017
High RiskFDA
Exact Sciences Corporation
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a...
Diagnostic Devices·15 affected·Apr 28, 2017
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transfe...
Medical Devices·2,718 affected·Apr 28, 2017
High RiskFDA
Kci Usa, Inc.
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Nega...
Surgical Devices·5,385 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Medical Devices·24 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32C...
Medical Devices·1,499 affected·Apr 28, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·3,331 affected·Apr 27, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·673 affected·Apr 27, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·0 affected·Apr 27, 2017
High RiskFDA
Rich Products Corp
7 OZ PIZZA DOUGH BALL, PRODUCT CODE 11267, UPC 0 00 49800 1267 4, NET CASE WT 12.9 KG (28 LB 7 OZ), UNIT NET WT: 198 G (7 OZ), COUNT: 65 ...
Food·13,043 affected·Apr 26, 2017
High RiskFDA
Rich Products Corp
ARTISAN CRUST PIZZA DOUGH 24/18, PRODUCT CODE 11413, UPC 1 00 49800 11413 2, NET CASE WT: 27 LB (12.2 KG), UNIT NET WT: 18 OZ (1 LB 2 OZ)...
Food·13,043 affected·Apr 26, 2017
High RiskFDA
Mccain Foods Usa
Wegman's O'Brien Hash Browns, frozen packages, net wt. 28 oz. UPC 07789036523.
Frozen Food·1,016 affected·Apr 26, 2017
High RiskFDA
Rich Products Corp
ARTISAN-STYLE PIZZA DOUGH BALL distributed under the following sizes and Product Codes: (a) 12 OZ ARTISAN-STYLE PIZZA DOUGH BALL, RICH'S ...
Food·13,043 affected·Apr 26, 2017
High RiskFDA
Iba Dosimetry
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
Medical Devices·110 affected·Apr 26, 2017
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Inte...
Medical Devices·437 affected·Apr 26, 2017
High RiskFDA
Ortho-clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2
Medical Devices·16 affected·Apr 26, 2017
High RiskFDA
Full Tilt Ice Cream
Label reads in part "***Full Tilt Ice Cream Fudge Brownie Swirl Vegan***one pint***Ingredients: Coconut Milk (coconut milk, water, citri...
Dairy·2,862 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Clarke-Reich Laparoscopic Knot Pusher
Medical Devices·178 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Stamey Needle
Medical Devices·698 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Endoscopic Introducer/Extractor
Medical Devices·46 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Pereyra-Raz Ligature Carrier
Medical Devices·257 affected·Apr 25, 2017
High RiskFDA
Biomerieux Sa
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susce...
Medical Devices·3,238 affected·Apr 25, 2017