DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 80 mg* recall — FDA D-0374-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
Latest records
Latest recalls — page 616
The newest recall records with useful source details are listed here.
DrugMar 8, 2023
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle recall — FDA D-0353-2023
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class IIFDA: TerminatedAlvogen, Inc.
DrugMar 8, 2023
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle recall — FDA D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle recall — FDA D-0354-2023
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class IIIFDA: TerminatedSciegen Pharmaceuticals Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur Folate 500 test kit- For in vitro diagnostic recall — FDA Z-1153-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur Folate 500 test kit (REF)-For in vitro recall — FDA Z-1154-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics Atellica IM Folate 700 test kit- For in vitro diagnostic use recall — FDA Z-1150-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
S & MOHR AMERICA, S.A. DE C.V abm Respiratory Care Standart Breating Circuit with Face Mask recall — FDA Z-1160-2023
Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"
Class IIIFDA: OngoingS & MOHR AMERICA, S.A. DE C.V.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use recall — FDA Z-1152-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG # recall — FDA Z-1157-2023
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss…
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMar 1, 2023
MEDLINE INDUSTRIES, LP - Northfield (1) Medline Sterile Maximum Barrier Pack-LF, Item recall — FDA Z-1162-2023
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceMar 1, 2023
Siemens Medical Solutions USA Luminos dRF with software VD10- A diagnostic imaging system recall — FDA Z-1166-2023
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMar 1, 2023
Siemens Medical Solutions USA Luminos Agile with software VC10 - A diagnostic imaging system recall — FDA Z-1164-2023
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMar 1, 2023
Access Vascular HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term recall — FDA Z-1156-2023
Label with the incorrect component listed on the inner kit Tyvek header bag
Class IIFDA: OngoingAccess Vascular, Inc.
Medical DeviceMar 1, 2023
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case recall — FDA Z-1161-2023
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceMar 1, 2023
MEDLINE INDUSTRIES, LP - Northfield (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits recall — FDA Z-1163-2023
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceMar 1, 2023
Draeger Medical NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 recall — FDA Z-1137-2023
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Class IFDA: OngoingDraeger Medical, Inc.
Medical DeviceMar 1, 2023
Siemens Medical Solutions USA Uroskop Omnia Max with software VE10 & VF11- A diagnostic recall — FDA Z-1168-2023
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic recall — FDA Z-1151-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T recall — FDA Z-1143-2023
Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics Atellica IM Folate 140 test kit- For in vitro diagnostic use recall — FDA Z-1149-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E recall — FDA Z-1159-2023
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss…
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMar 1, 2023
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D recall — FDA Z-1144-2023
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Class IIFDA: OngoingHologic, Inc.
Medical DeviceMar 1, 2023
Draeger Medical NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S) recall — FDA Z-1138-2023
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Class IFDA: OngoingDraeger Medical, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026110 records · 3 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories