DrugJan 18, 2023
Northern VA Compounders PLLC Methylcobalamin Injection Solution, 12.5mg/ml recall — FDA D-0119-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNorthern VA Compounders PLLC
January 2023 recalls — page 8
These records include useful source details for the selected month.
DrugJan 18, 2023
Northern VA Compounders PLLC TriMix Injection recall — FDA D-0118-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNorthern VA Compounders PLLC
DrugJan 18, 2023
Northern VA Compounders PLLC TriMix Injection recall — FDA D-0115-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNorthern VA Compounders PLLC
DrugJan 18, 2023
Northern VA Compounders PLLC QuadMix Plus recall — FDA D-0103-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNorthern VA Compounders PLLC
Medical DeviceJan 11, 2023
Steris VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number recall — FDA Z-0778-2023
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot…
Class IIFDA: OngoingSteris Corporation
Medical DeviceJan 11, 2023
Steris VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use recall — FDA Z-0780-2023
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot…
Class IIFDA: OngoingSteris Corporation
Medical DeviceJan 11, 2023
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For recall — FDA Z-0878-2023
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceJan 11, 2023
Randox Laboratories Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic recall — FDA Z-0905-2023
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 11, 2023
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only recall — FDA Z-0777-2023
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceJan 11, 2023
DeRoyal Tonsillectomy Tray, REF 89-10698.01 recall — FDA Z-0906-2023
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJan 11, 2023
Medtronic MiniMed Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of recall — FDA Z-0776-2023
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out,…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJan 11, 2023
Detect Covid-19 Test Product/Model Number: 21205 recall — FDA Z-0879-2023
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive…
Class IIFDA: OngoingDetect Headquarters
Medical DeviceJan 11, 2023
Randox Laboratories Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality recall — FDA Z-0903-2023
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 11, 2023
Steris VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number recall — FDA Z-0779-2023
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot…
Class IIFDA: OngoingSteris Corporation
Medical DeviceJan 11, 2023
Steris VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use recall — FDA Z-0781-2023
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot…
Class IIFDA: OngoingSteris Corporation
Medical DeviceJan 11, 2023
Randox Laboratories Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic recall — FDA Z-0904-2023
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 11, 2023
Siemens Medical Solutions USA Programmable Diagnostic Computer recall — FDA Z-0775-2023
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJan 11, 2023
Windstone Medical Packaging Various Custom Surgical Instrument Disposable Kits: Part Numbers recall — FDA Z-0881-2023
Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
FoodJan 11, 2023
THGH Partners Power Life by Tony Horton High Impact Plant Protein Chocolate recall — FDA F-0216-2023
Incorrect product label causing undeclared milk.
Class IFDA: TerminatedTHGH Partners, LLC
FoodJan 11, 2023
Cranberry Sweets & More Recalled Meltaways product is packaged in clear cellophane recall — FDA F-0214-2023
Peanut Butter Meltaway was mis-labeled as Mint Meltaways and peanut is undeclared.
Class IFDA: TerminatedCranberry Sweets & More Inc.
FoodJan 11, 2023
Sublime Desserts Members Mark Holiday Macarons 540g units in plastic trays, 10 recall — FDA F-0217-2023
Potential contamination of plastic particles.
Class IIFDA: TerminatedSublime Desserts Inc.
FoodJan 11, 2023
Four Seasons Produce Warehouse #2/Sunrise PROPAL, Hass Avocados , Bag of 6 pieces, Green net recall — FDA F-0215-2023
Sunrise Logistics Inc/ Four Seasons Produce Inc, 400 Wabash , Road Ephrata, PA 17522 has initiated a recall of, PROPAL Hass Avocados, Bag of 6 pieces, Green net with green plastic film, 11…
Class IIIFDA: TerminatedFour Seasons Produce Warehouse #2/Sunrise Logistics,…
DrugJan 11, 2023
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL) recall — FDA D-0095-2023
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class IIFDA: OngoingEugia US LLC
DrugJan 11, 2023
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride recall — FDA D-0097-2023
Lack of assurance of sterility: Bags have the potential to leak.
Class IIFDA: CompletedPfizer Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.