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High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Injectable Drugs·2,862 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tona...
Drugs·201 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmac...
Injectable Drugs·136 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuti...
Ophthalmic Drugs·2,181 affected·Oct 2, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Gastrointestinal Videoscope
Medical Devices·1,687 affected·Oct 2, 2023
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System
Medical Devices·3,961 affected·Oct 2, 2023
High RiskFDA
Stanbio Laboratory, Lp
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Diagnostic Devices·2,351 affected·Oct 2, 2023
High RiskFDA
Biomic Sciences, Llc Dba Ion Intelligence Of Nature
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Inhaled / Nasal Drugs·0 affected·Sep 29, 2023
High RiskFDA
Biomic Sciences, Llc Dba Ion Intelligence Of Nature
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Inhaled / Nasal Drugs·0 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Medical Implants·9 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Medical Implants·1 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Medical Implants·2 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Medical Devices·8 affected·Sep 29, 2023
High RiskFDA
Encore Medical, Lp
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Medical Devices·406 affected·Sep 29, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Surgical Devices·2,460 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Medical Devices·2 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Medical Implants·51 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Medical Implants·133 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Sentinel Ch Spa
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Diagnostic Devices·4,394 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Medical Implants·6 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Medical Devices·5 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Medical Implants·15 affected·Sep 29, 2023
High RiskFDA
Padagis Us Llc
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per ...
Topical Drugs·10,512 affected·Sep 28, 2023
High RiskFDA
Eugia Us Llc
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or I...
Injectable Drugs·1,626 affected·Sep 28, 2023
High RiskFDA
Abbott
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Medical Devices·34 affected·Sep 28, 2023
High RiskFDA
Olympus Corporation Of The Americas
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Medical Devices·75 affected·Sep 28, 2023
High RiskFDA
Infinant Health, Llc
Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommended Use: Thaw befor...
Dairy·3,257 affected·Sep 27, 2023
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Medical Devices·586 affected·Sep 27, 2023
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner bo...
Medical Devices·5,709 affected·Sep 27, 2023
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Medical Implants·29 affected·Sep 27, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medical Devices·77 affected·Sep 26, 2023
High RiskFDA
Path
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Medical Devices·1 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medical Devices·377 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Medical Devices·430 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Medical Devices·583 affected·Sep 26, 2023
High RiskFDA
B. Braun Medical, Inc.
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Medical Devices·12,800 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized ...
Medical Devices·0 affected·Sep 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPOINT 500 Blood Gas System
Medical Devices·12,363 affected·Sep 26, 2023
High RiskFDA
Path
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Medical Devices·28 affected·Sep 26, 2023
High RiskFDA
B. Braun Medical, Inc.
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microsph...
Medical Devices·760 affected·Sep 26, 2023
High RiskFDA
Path
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Medical Devices·15 affected·Sep 26, 2023
High RiskFDA
Penzeys, Ltd.
Penzeys Brady Street Cheese Sprinkle. Item 20756. net wt 2.2 oz (62g). Penzeys Spices, Wauwatosa, WI 53222.
Dairy·1,977 affected·Sep 25, 2023