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High RiskFDA
Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
Medical Devices·1 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Medical Devices·4 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Lara's Bakery 3 Llc
Panque (Pound Cake), Net Wt 2lbs, packaged in clear plastic bag.
Bakery & Grains·17,470 affected·Nov 30, 2023
High RiskFDA
Lara's Bakery 3 Llc
Chocoflan (Chocolate Custard Dessert), Net Wt 1/2 lb, packaged in plastic clamshell.
Snacks & Candy·17,470 affected·Nov 30, 2023
High RiskFDA
Lara's Bakery 3 Llc
Tres Leches (Three Milk Cake), Net Wt 1/2 lb, packaged in plastic clamshell.
Dairy·17,470 affected·Nov 30, 2023
High RiskFDA
Philips North America
BrightView X, Gamma Camera, Product Code 882478
Medical Devices·59 affected·Nov 30, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. P...
Medical Implants·1 affected·Nov 30, 2023
High RiskFDA
Philips North America
BrightView, Gamma Camera System, Product Code 882480.
Medical Devices·359 affected·Nov 30, 2023
High RiskFDA
Philips North America
BrightView XCT, Gamma Camera, Product Code 882482
Medical Devices·135 affected·Nov 30, 2023
High RiskFDA
Boston Scientific Corporation
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software us...
Cardiac Devices·14,328 affected·Nov 30, 2023
High RiskFDA
Gaws Gourmet Foods
Gaw's Classic Italian sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600920
Food·699 affected·Nov 29, 2023
High RiskFDA
Gaws Gourmet Foods
Gaw's XL Ham & Cheese sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC: 1725600925
Dairy·357 affected·Nov 29, 2023
High RiskFDA
Gaws Gourmet Foods
Gaw's Salami & Cheese Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600501
Dairy·150 affected·Nov 29, 2023
High RiskFDA
Gaws Gourmet Foods
Gaw's Deluxe Italian sub 12oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600910
Food·501 affected·Nov 29, 2023
High RiskFDA
Staq Pharma, Inc.
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd A...
Injectable Drugs·2,616 affected·Nov 29, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe Hemo
Medical Devices·331 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, ...
Medical Implants·12,291 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC E...
Medical Devices·804 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST ...
Medical Devices·144 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Centr...
Cardiac Devices·290 affected·Nov 29, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Series Copper (Cu) Assay Ref. Number CU2340
Diagnostic Devices·3,053 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR9...
Medical Devices·7,881 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; ...
Medical Devices·3,196 affected·Nov 29, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Medical Devices·2,100 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC K...
Medical Devices·244 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; ...
Medical Devices·1,020 affected·Nov 29, 2023
High RiskFDA
Waiakea Bottling Inc
Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrolytes Deep Well Water 1.0 Liter (33.8 FL OZ) Distributed by Waiakea Inc. PO B...
Beverages·3,850 affected·Nov 28, 2023
High RiskFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Medical Devices·18 affected·Nov 28, 2023
High RiskFDA
Mo-vis Bvba
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuverin...
Medical Devices·129 affected·Nov 28, 2023
High RiskFDA
Atricure, Inc.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Medical Devices·35 affected·Nov 28, 2023