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All Product Recalls
49,209 recalls (high severity)
High RiskFDA
Isotis Orthobiologics, Inc.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Medical Devices145 affectedNov 27, 2024
High RiskFDA
Curium Us, Llc
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each con...
Injectable Drugs5,160 affectedNov 26, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid h...
Diagnostic Devices362 affectedNov 26, 2024
High RiskFDA
O&m Halyard, Inc.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy P...
Medical Devices1,440 affectedNov 26, 2024
High RiskFDA
Macleods Pharmaceuticals Ltd
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured f...
Oral Drugs15,744 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Typ...
Surgical Devices128,608 affectedNov 25, 2024
High RiskFDA
Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory...
Medical Devices13,202 affectedNov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) ...
Medical Devices281 affectedNov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Medical Devices53 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices112 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Ty...
Surgical Devices495,865 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices4,055 affectedNov 25, 2024
High RiskFDA
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Medical Devices2,265 affectedNov 25, 2024
High RiskFDA
Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Medical Devices138 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices84,570 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices36,712 affectedNov 25, 2024
High RiskFDA
Spacelabs Healthcare, Ltd.
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to re...
Medical Devices1,779 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices9,200 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model N...
Surgical Devices34,325 affectedNov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; ...
Medical Devices120 affectedNov 25, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Respiratory Devices6,280 affectedNov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Respiratory Devices2,010 affectedNov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Respiratory Devices2,440 affectedNov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Respiratory Devices2,610 affectedNov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Respiratory Devices5,120 affectedNov 24, 2024
High RiskFDA
Provepharm Inc.
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springho...
Injectable Drugs2,160 affectedNov 22, 2024
High RiskFDA
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured ...
Injectable Drugs5,209 affectedNov 22, 2024
High RiskFDA
Generitech Corporation
10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Profession...
Drugs77 affectedNov 22, 2024
High RiskFDA
Apothecus Pharmaceutical Corp.
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmac...
Topical Drugs33,659 affectedNov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Medical Devices6 affectedNov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices670 affectedNov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices276 affectedNov 22, 2024
High RiskFDA
3m Company - Health Care Business
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-83...
Medical Devices171 affectedNov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical pr...
Diagnostic Devices2,240 affectedNov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical profes...
Diagnostic Devices6,738 affectedNov 22, 2024
High RiskFDA
Nipro Renal Soultions Usa, Corporation
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Medical Devices2,810 affectedNov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Medical Devices49 affectedNov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices320 affectedNov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Medical Devices10 affectedNov 22, 2024
High RiskFDA
Sugar Foods Llc
Fresh Gourmet TORTILLA STRIPS SANTA FE SYTLE NET WT 3.5 OZ (99g) UPC 7 87359 17504 6 DISTRIBUTED BY: FRESH GOURMET CO. WESTLAKE VILLAGE, ...
Food5,000 affectedNov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA P...
Cardiac Devices2,344 affectedNov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KI...
Medical Devices2,664 affectedNov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assi...
Surgical Devices84 affectedNov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ3518...
Medical Devices182 affectedNov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
See DocMan
Medical Devices205,360 affectedNov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and...
Surgical Devices100 affectedNov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Medical Devices128 affectedNov 21, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP a...
Medical Implants566 affectedNov 21, 2024