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High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Embrace Drill Tower, Wedged (25mm)
Medical Devices·6 affected·Jan 29, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Medical Devices·17 affected·Jan 29, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
MRI system: Vantage Elan, Model: MRT-2020
Medical Devices·1 affected·Jan 29, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Medical Devices·203 affected·Jan 29, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
Vantage Titan, Model: MRT-1504
Medical Devices·40 affected·Jan 29, 2024
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiple...
Diagnostic Devices·64,594 affected·Jan 26, 2024
High RiskFDA
Alphatec Spine, Inc.
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85...
Medical Devices·12,777 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Medical Devices·30 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·44 affected·Jan 26, 2024
High RiskFDA
In2bones, Sas
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Medical Devices·63 affected·Jan 26, 2024
High RiskFDA
Emd Millipore Corporation
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Diagnostic Devices·106 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Medical Devices·7 affected·Jan 26, 2024
High RiskFDA
In2bones, Sas
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Medical Devices·59 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·142 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Diagnostic Devices·1 affected·Jan 26, 2024
High RiskFDA
Lunds Mitchell Rd Llc
L&B Beautiful Morning Glory Muffins. Product #49025. 4 muffins per container. Net Wt 14 oz. UPC 18169-49025.
Food·1,092 affected·Jan 25, 2024
High RiskFDA
Amerisource Health Services Llc
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC...
Oral Drugs·1,932 affected·Jan 25, 2024
High RiskFDA
Alpha Aromatics
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA ...
Drugs·676 affected·Jan 25, 2024
High RiskFDA
Voco Gmbh
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Medical Devices·1,021 affected·Jan 25, 2024
High RiskFDA
Mutti Usa Inc.
MUTTI Crushed Tomatoes; Polpa; Net Wt 27.9 OZ (1lb 11.9 OZ) 790g; UPC 85469300071
Produce·137,634 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Medical Devices·30 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacia...
Medical Devices·10 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe f...
Medical Devices·5 affected·Jan 24, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Diagnostic Devices·1,057 affected·Jan 24, 2024
High RiskFDA
Thommen Medical Ag
impression coping, repositionable, short, screw-retained, PF 4.0
Medical Devices·20 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number:...
Medical Devices·11 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Surgical Devices·17 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Medical Devices·47 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Surgical Devices·30 affected·Jan 24, 2024
High RiskFDA
Baxter Healthcare Corporation
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter...
Injectable Drugs·13,000 affected·Jan 23, 2024
High RiskFDA
Integradose Compounding Services Llc
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kaso...
Injectable Drugs·1,299 affected·Jan 22, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractu...
Medical Devices·0 affected·Jan 22, 2024
High RiskFDA
B. Braun Medical, Inc.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for th...
Surgical Devices·3,890 affected·Jan 22, 2024
High RiskFDA
Invacare Corporation
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC ...
Medical Devices·8,117 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System (New and Refurbished)
Medical Devices·1,460 affected·Jan 22, 2024
High RiskFDA
Sedecal Sa
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40...
Diagnostic Devices·636 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT7600 Integrated System
Medical Devices·1,720 affected·Jan 22, 2024
High RiskFDA
B. Braun Medical, Inc.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tr...
Surgical Devices·3,480 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Diagnostic Devices·489 affected·Jan 22, 2024
High RiskFDA
New World Company
Fortune cookies, individually wrapped in a 6lb case, 190 pcs / case
Bakery & Grains·0 affected·Jan 19, 2024
High RiskFDA
New World Company
Fortune cookies, 1 lb plastic retail bags
Bakery & Grains·600 affected·Jan 19, 2024
High RiskFDA
Lydia Pack 3 Inc
Al Amir Fresh Foods Tzatziki Cucumber Yogurt, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. U...
Dairy·3,000 affected·Jan 19, 2024
High RiskFDA
New World Company
Bulk case of Fortune cookies, labeled as 6 lb (1.3 lb per bag/ 4 bags per case)
Bakery & Grains·600 affected·Jan 19, 2024
High RiskFDA
Bestco Llc
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Ro...
Oral Drugs·78 affected·Jan 19, 2024
High RiskFDA
Bestco Llc
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, ...
Oral Drugs·16 affected·Jan 19, 2024
High RiskFDA
Bestco Llc
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, ...
Oral Drugs·21 affected·Jan 19, 2024
High RiskFDA
Bestco Llc
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, it...
Oral Drugs·1,597 affected·Jan 19, 2024
High RiskFDA
Omeza Llc
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Topical Drugs·1,210 affected·Jan 19, 2024