DrugDec 11, 2024
Aurobindo Pharma USA Cinacalcet Tablets, 30 mg recall — FDA D-0077-2025
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class IIFDA: OngoingAurobindo Pharma USA Inc
December 2024 recalls — page 11
These records include useful source details for the selected month.
DrugDec 11, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage recall — FDA D-0097-2025
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugDec 11, 2024
Aurobindo Pharma USA Cinacalcet Tablets, 60mg recall — FDA D-0078-2025
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class IIFDA: OngoingAurobindo Pharma USA Inc
VehicleDec 5, 2024
Toyota Motor Engineering & Manufacturing caliper recall — NHTSA campaign 24V911000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2024 RAV4 and 2025 Lexus NX vehicles. Some of the bolts that secure the front brake caliper and the wheel hub bearing…
caliperToyota Motor Engineering & Manufacturing
VehicleDec 5, 2024
X3 30 wheel bearing recall — NHTSA campaign 24V909000
BMW of North America, LLC (BMW) is recalling certain 2025 X3 30 vehicles. The front wheel left-side swivel bearing may crack, causing a loss of vehicle handling and control.
wheel bearingBMW of North America, LLC
Medical DeviceDec 4, 2024
LivaNova Deutschland GmbH Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software recall — FDA Z-0571-2025
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second…
Class IIFDA: OngoingLivaNova Deutschland GmbH
Medical DeviceDec 4, 2024
Remote Diagnostic Technologies Tempus LS-Manual Defibrillator Model 00-3020 The Tempus recall — FDA Z-0557-2025
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Class IIIFDA: OngoingRemote Diagnostic Technologies Ltd.
Medical DeviceDec 4, 2024
Abbott Medical Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 recall — FDA Z-0552-2025
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Class IIIFDA: OngoingAbbott Medical
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482 recall — FDA Z-0567-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 4, 2024
MEDLINE INDUSTRIES, LP - Northfield ENDO KIT, Medline Kit SKU DYKE1577A, Component Number recall — FDA Z-0558-2025
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceDec 4, 2024
Shimadzu Corp. Analytical & Measuring Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL recall — FDA Z-0553-2025
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious…
Class IIFDA: OngoingShimadzu Corp. Analytical & Measuring Instruments Div.
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484 recall — FDA Z-0566-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 4, 2024
GE Medical Systems Tomographic Imager Combining Emission Computed Tomography With Nuclear recall — FDA Z-0520-2025
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482 recall — FDA Z-0563-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483 recall — FDA Z-0565-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 4, 2024
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human recall — FDA Z-0522-2025
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed…
Class IIFDA: OngoingKreatech Biotechnology Bv
Medical DeviceDec 4, 2024
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View recall — FDA Z-0505-2025
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
Class IIFDA: OngoingDefibtech, LLC
Medical DeviceDec 4, 2024
Ortho-Clinical Diagnostics VITROS Chemistry Products CRP Slides- In vitro diagnostic recall — FDA Z-0535-2025
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceDec 4, 2024
Karl Storz Endoscopy 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm recall — FDA Z-0526-2025
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S recall — FDA Z-0561-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 4, 2024
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699 recall — FDA Z-0515-2025
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceDec 4, 2024
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline recall — FDA Z-0502-2025
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
Class IIFDA: OngoingDefibtech, LLC
Medical DeviceDec 4, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and recall — FDA Z-0503-2025
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
Class IIFDA: OngoingDefibtech, LLC
Medical DeviceDec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E recall — FDA Z-0564-2025
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class IIFDA: OngoingBaxter Healthcare Corporation
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.