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High RiskFDA
Piantedosi Baking Co., Inc.
Sunset Burger Roll 12-pack (033474504187)
Food·18,119 affected·Aug 17, 2022
High RiskFDA
Piantedosi Baking Co., Inc.
Brioche Style Burger Roll 12-pack (033474504170)
Food·18,119 affected·Aug 17, 2022
High RiskFDA
Piantedosi Baking Co., Inc.
Gourmet Potato Slider Rolls 24-pack (033474512045)
Food·18,119 affected·Aug 17, 2022
High RiskFDA
Padagis Us Llc
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, M...
Topical Drugs·57,816 affected·Aug 17, 2022
High RiskFDA
Abbott Nutrition
Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per case
Food·720 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3...
Medical Devices·9,903 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-...
Medical Devices·25 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0...
Medical Devices·240 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Medical Devices·42 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09...
Medical Devices·488 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Medical Devices·115 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colos...
Medical Devices·3,209 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-...
Medical Devices·5,041 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a ...
Medical Devices·182 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH...
Medical Devices·204 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Medical Devices·58 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 ...
Medical Devices·150 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-CO...
Medical Devices·2,748 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Medical Devices·149 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-03...
Medical Devices·56 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Medical Devices·363 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 ...
Medical Devices·5,571 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a col...
Medical Devices·5,284 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Medical Devices·43 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-...
Medical Devices·1,236 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Pepsico Inc
Starbucks Vanilla Espresso Triple Shot, 15 oz, 12 bottles per case.
Food·221 affected·Aug 15, 2022
High RiskFDA
Ultra Chem Labs Corp
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water ...
Drugs·5 affected·Aug 15, 2022
High RiskFDA
Ultra Chem Labs Corp
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24...
Drugs·5 affected·Aug 15, 2022
High RiskFDA
King's Hawaiian Bakery
King's Hawaiian 10.5 oz. Pretzel Hamburger Buns (UPC 73435000365), 10.2 oz. Pretzel Bites (UPC 73435000525.), and 11 oz. Slider Buns (UP...
Food·800,111 affected·Aug 12, 2022
High RiskFDA
Kraft Heinz Foods Company
Capri Sun, Wild Cherry, Flavored Juice Drink Blend in 6floz. foil pouch. Sold in carton containing 10 pouches. Carton UPC 087684001004. ...
Beverages·5,760 affected·Aug 12, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Medical Devices·1,306 affected·Aug 12, 2022
High RiskFDA
Encore Medical, Lp
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Medical Implants·4 affected·Aug 12, 2022
High RiskFDA
Chamberlain Technologies Llc
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Surgical Devices·20 affected·Aug 12, 2022
High RiskFDA
Coopersurgical, Inc.
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Medical Devices·5,182 affected·Aug 12, 2022
High RiskFDA
Coopersurgical, Inc.
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no ...
Medical Devices·5,182 affected·Aug 12, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in...
Surgical Devices·231 affected·Aug 12, 2022
High RiskFDA
Chamberlain Technologies Llc
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Surgical Devices·10 affected·Aug 12, 2022
High RiskFDA
Encore Medical, Lp
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Medical Implants·18 affected·Aug 12, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-...
Medical Implants·11,143 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, RE...
Medical Implants·132 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF ...
Medical Implants·1,017 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL...
Medical Implants·3,793 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, ...
Medical Implants·17,929 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS,...
Medical Implants·58,158 affected·Aug 11, 2022
High RiskFDA
Family Dollar Stores, Llc.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 3500...
Drugs·1,120 affected·Aug 10, 2022