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High RiskFDA
Neurovision Medical Products Inc
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Medical Devices·5 affected·Jul 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size...
Surgical Devices·4,364 affected·Jul 1, 2024
High RiskFDA
Canadian Art Prints
UPC 772665860106. PLT010. Indigenous Collection Signature Plates set - Dancing Bears & Three Bears on box and back of plate. Art by Dawn ...
Food·161 affected·Jun 28, 2024
High RiskFDA
Canadian Art Prints
UPC Code 772665860083, Stock code PLT008, Indigenous Collection Signature Plates set - Not Forgotten & Ancient Messages. Artist Maxine No...
Food·301 affected·Jun 28, 2024
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, C...
Oral Drugs·116,144 affected·Jun 28, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, M...
Oral Drugs·145,800 affected·Jun 28, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by heal...
Medical Devices·18 affected·Jun 28, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by heal...
Medical Devices·4 affected·Jun 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Surgical Devices·400 affected·Jun 28, 2024
High RiskFDA
Lipari Foods Operating Company, Llc.
Premo King Club Footlong 11.5oz, clear plastic, UPC 612510094259, 4 retail packages per wholesale case
Food·216 affected·Jun 27, 2024
High RiskFDA
Lipari Foods Operating Company, Llc.
Premo Turkey & Swiss 6oz, clear plastic, UPC 612510001042, 4 retail packages per wholesale case
Meat & Poultry·588 affected·Jun 27, 2024
High RiskFDA
Lipari Foods Operating Company, Llc.
Premo Meat Lovers 7oz, clear plastic, UPC 612510093832, 4 retail packages per wholesale case
Meat & Poultry·638 affected·Jun 27, 2024
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd...
Injectable Drugs·432,250 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB ...
Medical Devices·720 affected·Jun 27, 2024
High RiskFDA
Link Bio Corp
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Medical Devices·8 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Medical Devices·55 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b...
Medical Devices·29,585 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
Medical Devices·35 affected·Jun 27, 2024
High RiskFDA
Medivance Inc.
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic S...
Medical Devices·10,507 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO B...
Medical Devices·6,257 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENER...
Medical Devices·358 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCH...
Medical Devices·3,117 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; ...
Medical Devices·407 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
Medical Devices·444 affected·Jun 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK10...
Cardiac Devices·1,646 affected·Jun 27, 2024
High RiskFDA
Boston Scientific Corporation
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturin...
Medical Implants·70,890 affected·Jun 27, 2024
High RiskFDA
Remedyrepack Inc.
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Rep...
Oral Drugs·142 affected·Jun 26, 2024
High RiskFDA
Medisca Inc.
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38...
Drugs·113 affected·Jun 26, 2024
High RiskFDA
Equibal Inc
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 0...
Drugs·90 affected·Jun 26, 2024
High RiskFDA
Guru Inc.
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hw...
Oral Drugs·0 affected·Jun 26, 2024
High RiskFDA
Siemens Ag/siemens Healthcare Gmbh
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures incl...
Diagnostic Devices·201 affected·Jun 26, 2024
High RiskFDA
Siemens Ag/siemens Healthcare Gmbh
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures incl...
Diagnostic Devices·201 affected·Jun 26, 2024
High RiskFDA
Feng Chun Yuan Medical Equipment (shenzhen)co.,ltd
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Diagnostic Devices·120,000 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Medical Devices·109,563 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Medical Devices·120,960 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Medical Devices·125,928 affected·Jun 26, 2024
High RiskFDA
Feng Chun Yuan Medical Equipment (shenzhen)co.,ltd
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Diagnostic Devices·150,000 affected·Jun 26, 2024
High RiskFDA
Feng Chun Yuan Medical Equipment (shenzhen)co.,ltd
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Diagnostic Devices·50,000 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Medical Devices·2,881,080 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion...
Medical Devices·156,400 affected·Jun 26, 2024
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. ...
Surgical Devices·26,400 affected·Jun 26, 2024
High RiskFDA
Preat Corp
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-...
Medical Devices·185 affected·Jun 25, 2024
High RiskFDA
Fgf Brands, Inc
Bakeshop Chocolate Chip Muffin 4 count, in clear plastic clamshell, UPC 4099100048278. 5 retail units per case.
Snacks & Candy·11,830 affected·Jun 24, 2024
High RiskFDA
Pastaurora Llc
Campanelle (vegan) Dried, net wt. 10oz. in clear package with green/back printings on whie label. UPC 850049624022.
Food·27 affected·Jun 24, 2024
High RiskFDA
Amerisource Health Services Llc
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: ...
Oral Drugs·2,484 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Medical Devices·61 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
Medical Devices·1 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
Medical Devices·4 affected·Jun 24, 2024