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RecallFDA
Lin-zhi International Inc
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster de...
Diagnostic Devices·49 affected·Jan 11, 2019
High RiskFDA
Aap Implantate Ag
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of b...
Medical Implants·25 affected·Jan 11, 2019
High RiskFDA
Major Pharmaceuticals
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17...
Oral Drugs·3,102 affected·Jan 10, 2019
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGu...
Injectable Drugs·146 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quant...
Diagnostic Devices·304 affected·Jan 10, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. Th...
Medical Implants·110 affected·Jan 10, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees....
Medical Implants·538 affected·Jan 10, 2019
High RiskFDA
Bio-rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Medical Devices·213 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitat...
Diagnostic Devices·31 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quant...
Diagnostic Devices·79 affected·Jan 10, 2019
High RiskFDA
Arrow International Inc
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Surgical Devices·45 affected·Jan 10, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufacture...
Oral Drugs·14,400 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·15,064 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary ...
Surgical Devices·5,744,525 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·11,332 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duo...
Medical Devices·1,231,155 affected·Jan 9, 2019
High RiskFDA
Neusoft Medical Systems Imp & Ex
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be u...
Medical Devices·3 affected·Jan 9, 2019
CriticalFDA
Winter Gardens Quality Foods, Inc.
Chips & Chocolate, A layered dessert with chocolate mousse layer on the bottom, with a white whipped topping layer on top topped with cho...
Snacks & Candy·138 affected·Jan 8, 2019
CriticalFDA
Happy Together, Inc.
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Oral Drugs·0 affected·Jan 8, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to sup...
Surgical Devices·6 affected·Jan 8, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is de...
Surgical Devices·6 affected·Jan 8, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product ...
Surgical Devices·6 affected·Jan 8, 2019
CriticalFDA
Pizza Blends, Llc
The Great American by Pizza Blends, Pizza Dough Mix With Yeast, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 24 lb bags.
Food·1,280 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
FourStar Pizza & Subs, Pizza Dough Premix, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 26 lb bags.
Food·1,680 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
Paul Revere's Pizza, Pizza Crust Mix, Manufactured by Pizza Blends Bellevue, WA packaged in 26.70 lb bags.
Food·269 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
The Great American by Pizza Blends, Pizza Dough Mix No Yeast, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 24 lb bags.
Food·1,004 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
Peter Piper, Two-N-One Dough, Manufactured Exclusively for Peter Piper Pizza, Phoenix, AZ. packaged in 26 lb bags.
Food·826 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
Village Pizza & Seafood, Custom Pizza Flour, Manufactured Exclusively for Village Pizza & Seafood League City, TX, packaged in 21.7 lb bags.
Seafood·198 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
CEC Entertainment, Inc., Proprietary Pizza Dough Premix, Manufactured Exclusively for CEC Entertainment, Irving, TX packaged in 24 lb bags.
Food·52,718 affected·Jan 7, 2019
CriticalFDA
Pizza Blends, Llc
CEC Entertainment, Inc., No Yeast Proprietary Pizza Dough Premix, Manufactured Exclusively for CEC Entertainment, Irving, TX packaged in ...
Food·1,916 affected·Jan 7, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Ma...
Oral Drugs·7,215 affected·Jan 7, 2019
High RiskFDA
Linet Spol. S.r.o.
AVE 2 Birthing Bed
Medical Devices·253 affected·Jan 7, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Op...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Medical Devices·72 affected·Jan 7, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Teleflex Medical
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Medical Devices·80 affected·Jan 7, 2019
CriticalFDA
Hy-vee Stores Inc
HyVee brand Pumpkin-fluff -flavored cheese cakes packaged in the following ways: 1) Pumpkin-fluff Cheesecake, Net Wt. 7 OZ, HyVee West...
Dairy·2,608 affected·Jan 4, 2019
CriticalFDA
Hy-vee Stores Inc
HyVee brand Smores-flavored Bettercreme cheese cakes packaged in the following ways: 1) Smores Bettercreme Cheesecake, Net Wt. 7 OZ, H...
Dairy·2,608 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
MEMBERS MARK SELF RISE FLR 25LB
Food·0 affected·Jan 4, 2019
CriticalFDA
Diamond Crystal Brands, Inc.
Chocolate instant pudding and pie filling mix packaged in the following ways: 1) Classic Sysco Chocolate Instant Pudding & Pie Filling...
Snacks & Candy·6,480 affected·Jan 4, 2019
High RiskFDA
Grand Strand Sandwich Company,inc.
LUNCH BOX SANDWICHES HAM & CHEESE CROISSANT; NET WT 5OZ (142G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67062 21217 2
Dairy·140 affected·Jan 4, 2019
CriticalFDA
Hy-vee Stores Inc
HyVee brand Golden Oreo-flavored cheese cakes packaged in the following ways: 1) Golden Oreo Bettercreme Cheesecake, Net Wt. 7 OZ, HyV...
Dairy·2,608 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
WESTCREEK H&R SELF RISE AP FLR 25LB and 50LB
Food·0 affected·Jan 4, 2019
CriticalFDA
Diamond Crystal Brands, Inc.
Chocolate instant pudding and pie filling packaged in the following ways: 1) Chef's Companion Sugar Free, Reduced Calorie, Instant Cho...
Snacks & Candy·1,150 affected·Jan 4, 2019
CriticalFDA
Hy-vee Stores Inc
HyVee brand Pumpkin-flavored Bettercreme cheese cakes packaged in the following ways: 1) Pumpkin Bettercreme Cheesecake, Net Wt. 7 OZ,...
Dairy·2,608 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
HILLTOP HEARTH SELF RISE FLR 25LB and 50LB
Food·0 affected·Jan 4, 2019
CriticalFDA
Hy-vee Stores Inc
HyVee brand turtle-flavored cheese cakes packaged in the following ways: 1) Turtle Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA...
Dairy·2,608 affected·Jan 4, 2019
CriticalFDA
Diamond Crystal Brands, Inc.
Chef's Companion Sugar Free, Reduced Calorie, Instant Chocolate Pudding & Pie Filling, Net Wt. 3.5 OZ, Distributed By Diamond Crystal Bra...
Snacks & Candy·168 affected·Jan 4, 2019