DrugMay 8, 2024
EYLEA recall — FDA D-0479-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
Class IIFDA: TerminatedRegeneron Pharmaceuticals Inc.
May 2024 recalls — page 16
These records include useful source details for the selected month.
DrugMay 8, 2024
Valacyclovir Tablets USP, 500 mg, 90 count bottles recall — FDA D-0481-2024
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class IIIFDA: CompletedViatris Inc.
DrugMay 8, 2024
Hikma Injectables USA Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection recall — FDA D-0480-2024
Labeling: Wrong Barcode
Class IIIFDA: CompletedHikma Injectables USA Inc.
Medical DeviceMay 1, 2024
Covidien Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm recall — FDA Z-1635-2024
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Class IIFDA: OngoingCovidien LP
Medical DeviceMay 1, 2024
Siemens Medical Solutions USA ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791 recall — FDA Z-1599-2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests recall — FDA Z-1636-2024
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results,…
Class IIFDA: OngoingQuidel Corporation
Medical DeviceMay 1, 2024
CLEANER BOTTLE recall — FDA Z-1686-2024
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not…
Class IIFDA: OngoingElectro Medical Systems SA
Medical DeviceMay 1, 2024
EBI Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment recall — FDA Z-1617-2024
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
Class IIFDA: OngoingEBI, LLC
Medical DeviceMay 1, 2024
Alcon Research Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang recall — FDA Z-1606-2024
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
Class IIFDA: OngoingAlcon Research, LLC
Medical DeviceMay 1, 2024
EBI 20" Lead Wires, Replacement Part Number: 1067724-2 recall — FDA Z-1618-2024
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
Class IIFDA: OngoingEBI, LLC
Medical DeviceMay 1, 2024
Howmedica Osteonics TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision recall — FDA Z-1625-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceMay 1, 2024
Howmedica Osteonics TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision recall — FDA Z-1621-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceMay 1, 2024
3M Company - Health Care Business 3M Durapore Surgical Tape, Catalog Number 1538-118 recall — FDA Z-1633-2024
Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.
Class IIFDA: Ongoing3M Company - Health Care Business
Medical DeviceMay 1, 2024
Howmedica Osteonics TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision recall — FDA Z-1629-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceMay 1, 2024
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1 recall — FDA Z-1690-2024
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 1, 2024
Parker Laboratories Redux Electrolyte Creme, Product Ref. 66-04 recall — FDA Z-1604-2024
Product demonstrates low viscosity.
Class IIFDA: OngoingParker Laboratories, Inc.
Medical DeviceMay 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests recall — FDA Z-1637-2024
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results,…
Class IIFDA: OngoingQuidel Corporation
Medical DeviceMay 1, 2024
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO recall — FDA Z-1614-2024
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class IFDA: OngoingROUTE 92 MEDICAL Inc.
Medical DeviceMay 1, 2024
Howmedica Osteonics TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision recall — FDA Z-1626-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceMay 1, 2024
Siemens Medical Solutions USA ACUSON Maple Diagnostic Ultrasound System, REF: 11711750 recall — FDA Z-1601-2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 1, 2024
Howmedica Osteonics TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision recall — FDA Z-1624-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceMay 1, 2024
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO recall — FDA Z-1610-2024
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Class IFDA: OngoingROUTE 92 MEDICAL Inc.
Medical DeviceMay 1, 2024
Biomerieux VITEK 2 - AST Test kits recall — FDA Z-1464-2024
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for…
Class IFDA: OngoingBiomerieux Inc.
Medical DeviceMay 1, 2024
EBI Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the recall — FDA Z-1616-2024
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
Class IIFDA: OngoingEBI, LLC
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.