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High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and ...
Medical Devices·241 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and...
Medical Devices·1,063 affected·May 26, 2023
High RiskFDA
Cricket Creek Farm Llc
Cricket Creek Farm brand Berkshire Bloom Cheese
Dairy·140 affected·May 25, 2023
High RiskFDA
Ask Foods Inc
Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ (1 LB 14 OZ) 850 g. Packaged in a plastic container.
Produce·600 affected·May 25, 2023
High RiskFDA
Cricket Creek Farm Llc
Cricket Creek Farm brand Tobasi cheese
Dairy·250 affected·May 25, 2023
High RiskFDA
Cricket Creek Farm Llc
Cricket Creek Farm brand Feta Cheese
Dairy·184 affected·May 25, 2023
High RiskFDA
Entrinsic Health Solution Inc
enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recom...
Beverages·43,336 affected·May 25, 2023
High RiskFDA
Viatris Inc
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Dis...
Injectable Drugs·2,736 affected·May 25, 2023
High RiskFDA
Golden State Medical Supply Inc.
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incor...
Ophthalmic Drugs·1,920 affected·May 25, 2023
High RiskFDA
Teleflex Llc
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Medical Devices·170 affected·May 25, 2023
High RiskFDA
Teleflex Llc
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Medical Devices·365 affected·May 25, 2023
High RiskFDA
Teleflex Llc
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
Medical Devices·32 affected·May 25, 2023
High RiskFDA
T.w. Garner Food Co
Texas Pete BUFFALO Wing Sauce 12 FL OZ - 355 mL TW GARNER FOOD CO. WINSTON-SALEM, NC 27105 UPC 0 75500 10011 6
Food·4,224 affected·May 24, 2023
High RiskFDA
Cytocell Ltd.
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA seq...
Medical Devices·61 affected·May 24, 2023
High RiskFDA
Neumodx Molecular Inc
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molec...
Medical Devices·20,016 affected·May 24, 2023
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is...
Medical Devices·1,980 affected·May 24, 2023
High RiskFDA
Phadia Ab
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Diagnostic Devices·124,928 affected·May 24, 2023
High RiskFDA
Central America Products Corporation
Soft Cream Spread, Net Wt 16oz (1lb)
Dairy·34 affected·May 23, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ...
Injectable Drugs·53,424 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8...
Medical Devices·10,159 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Medical Devices·9,215 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20...
Medical Devices·13,390 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Medical Devices·52 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed ...
Medical Devices·30,528 affected·May 23, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Medical Devices·106 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Medical Devices·1,689 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Medical Devices·4,159 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Medical Devices·7,264 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Medical Devices·199 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Medical Devices·665 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, ...
Medical Devices·3,992 affected·May 23, 2023
High RiskFDA
Aurobindo Pharma Usa Inc.
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wil...
Drugs·87,360 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Medical Devices·1,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS Pregnancy Test Midstream REF 100-17
Medical Devices·3,304 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
Lem Fertility hCG Pregnancy Urine Test REF 100-12
Medical Devices·2,500 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
Medical Devices·4,103 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
Medical Devices·40,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
One Step Pregnancy Test REF 100-01
Medical Devices·147,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Diagnostic Devices·122,500 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Medical Devices·2,400 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Medical Devices·25,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS One Step LH Ovulation Test Strip REF 200-07
Medical Devices·525 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Medical Devices·1,000 affected·May 22, 2023