DrugJun 22, 2022
SUN PHARMACEUTICAL INDUSTRIES medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 recall — FDA D-1147-2022
Lack of assurance of sterility
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
June 2022 recalls — page 5
These records include useful source details for the selected month.
DrugJun 22, 2022
SUN PHARMACEUTICAL INDUSTRIES medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL recall — FDA D-1144-2022
Lack of assurance of sterility
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJun 22, 2022
Walmart Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles recall — FDA D-1159-2022
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class IIFDA: CompletedWalmart Inc.
DrugJun 22, 2022
Walmart Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles recall — FDA D-1158-2022
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class IIFDA: CompletedWalmart Inc.
VehicleJun 16, 2022
General Motors rear recall — NHTSA campaign 22V427000
General Motors, LLC (GM) is recalling certain 2022 Cadillac XT5, XT6, and GMC Acadia vehicles. The left-rear suspension toe link may have been tightened improperly, which could result in a…
rearGeneral Motors, LLC
Medical DeviceJun 15, 2022
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber recall — FDA Z-1248-2022
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip…
Class IIFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceJun 15, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 recall — FDA Z-1251-2022
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing…
Class IIFDA: OngoingNeuMoDx Molecular Inc.
Medical DeviceJun 15, 2022
Siemens Medical Solutions USA Artis icono floor-angiography systems developed for single and recall — FDA Z-1246-2022
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJun 15, 2022
Encore Medical DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 recall — FDA Z-1257-2022
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceJun 15, 2022
GE Healthcare Back up batteries in Ventilators labeled as the following: a recall — FDA Z-1226-2022
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Class IFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
GE Healthcare Centricity PACS RA1000 recall — FDA Z-1233-2022
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
Siemens Medical Solutions USA Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 recall — FDA Z-1243-2022
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJun 15, 2022
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector recall — FDA Z-1249-2022
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip…
Class IIFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceJun 15, 2022
GE Healthcare Centricity Cardiology CA1000 recall — FDA Z-1232-2022
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote recall — FDA Z-1254-2022
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert…
Class IIFDA: TerminatedMedminder Systems, Inc.
Medical DeviceJun 15, 2022
Siemens Medical Solutions USA Artis icono biplane -angiography systems developed for single recall — FDA Z-1245-2022
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJun 15, 2022
GE Healthcare Replacement back up batteries distributed on or after April 1, 2019, for recall — FDA Z-1227-2022
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Class IFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
GE Healthcare Centricity Enterprise Web recall — FDA Z-1230-2022
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
GE Healthcare Centricity Universal Viewer Zero Footprint Client recall — FDA Z-1229-2022
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
GE Healthcare Centricity Radiology RA600 recall — FDA Z-1231-2022
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 15, 2022
Oakworks Bed (Emergency Field Bed) recall — FDA Z-1239-2022
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Class IIFDA: TerminatedOakworks Inc.
Medical DeviceJun 15, 2022
BSN Medical (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped recall — FDA Z-1228-2022
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Class IIFDA: TerminatedBSN Medical Inc.
Medical DeviceJun 15, 2022
Siemens Healthcare Diagnostics Atellica IM 1600 Analyzer - automated, immunoassay analyzer recall — FDA Z-1253-2022
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceJun 15, 2022
Oakworks PX200 Emergency Relief Bed recall — FDA Z-1238-2022
Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Class IIFDA: TerminatedOakworks 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.