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High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Medical Devices·27 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Medical Devices·20 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Medical Devices·23 affected·Sep 8, 2020
High RiskFDA
Esaote S.p.a
AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following ...
Diagnostic Devices·989 affected·Sep 8, 2020
RecallFDA
Devicor Medical Products Inc
Neoprobe GDS Control Unit, Model Number NPCU3
Medical Devices·49 affected·Sep 7, 2020
High RiskFDA
Coolhaus
Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich; Chocolate chip cookies, cookie dough batter with gobs of cookie dough....
Dairy·78,160 affected·Sep 5, 2020
CriticalFDA
Toufayan Bakery, Inc.
Goodie Girl, Gluten Free Magical Animal Crackers, 7 ounce , paper cartons, 6 packages per case, Best By JAN 11 21 A3
Bakery & Grains·385 affected·Sep 4, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Deliver...
Topical Drugs·32,543 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Medical Devices·33 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Medical Devices·4 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet Regenerex Primary Taper Cap Item Number 141269
Medical Devices·62 affected·Sep 4, 2020
High RiskFDA
Braxton Medical Corporation
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to ...
Surgical Devices·1,781 affected·Sep 4, 2020
CriticalFDA
Ab Ulax
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance h...
Respiratory Devices·1,484,100 affected·Sep 4, 2020
RecallFDA
Herr Foods Inc
Herr s GameDay Tailgate Tacos Flavored Potato Chips 6.5 oz. packaged in a flexible metalized bag. UPC Code: 7260006434
Snacks & Candy·1,571 affected·Sep 3, 2020
High RiskFDA
Ajr Trading Llc
bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos H...
Topical Drugs·2,000 affected·Sep 3, 2020
CriticalFDA
Corgiomed Llc
Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495...
Drugs·28,900 affected·Sep 3, 2020
High RiskFDA
Akorn, Inc.
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, ND...
Ophthalmic Drugs·25,843 affected·Sep 3, 2020
High RiskFDA
Allison Medical, Inc.
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Medical Devices·2,004 affected·Sep 3, 2020
High RiskFDA
Biomet, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 1100104...
Medical Devices·48 affected·Sep 3, 2020
CriticalFDA
Tim Campbell Farm Llc
Tim Campbell Farm flat parsley in wooden crate. Neither Net weight nor quantity stated on label; product is 30 count.
Food·210 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottl...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets,...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·600 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottle...
Drugs·0 affected·Sep 2, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·3,900 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tabl...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Ph-d Feminine Health
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, ...
Drugs·37,000 affected·Sep 2, 2020
High RiskFDA
Biomet, Inc.
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage...
Medical Implants·3 affected·Sep 2, 2020
High RiskFDA
Gentian As
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012,...
Medical Devices·107 affected·Sep 2, 2020
CriticalFDA
The Protein Shoppe
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Oral Drugs·21,511 affected·Sep 1, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and ...
Medical Devices·15 affected·Sep 1, 2020
High RiskFDA
Medline Industries Inc
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal...
Surgical Devices·6,225 affected·Sep 1, 2020
High RiskFDA
Fresco Foods
Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook T...
Produce·1,096 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3...
Medical Devices·231,250 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Medical Devices·2,900 affected·Aug 31, 2020
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices·271 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spir...
Medical Devices·19,850 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Dri...
Medical Devices·217,522 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Medical Devices·2 affected·Aug 31, 2020
High RiskFDA
Encore Medical, Lp
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shou...
Surgical Devices·15 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Medical Devices·325 affected·Aug 31, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Us...
Surgical Devices·5,813 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Medical Devices·10 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip ...
Medical Devices·55,000 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Medical Devices·9 affected·Aug 31, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter.
Surgical Devices·89,121 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Medical Devices·900 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Medical Devices·35 affected·Aug 31, 2020