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All product recalls associated with Osteomed, LLC.
Total Recalls
1000
Past Year
353
Class I (Serious)
22
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
There is a potential for the outer white Tyvek lid to debond from the sealed package.
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Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Products may be contaminated with Listeria monocytogenes.
There is potential for intermittent electrical connectivity between the console and probe.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
There is a breach in the product packaging that renders the product non-sterile.
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
This recall involves Step2's StepUp Sidekick Learning Tower for children. The tower can be used as a helper stool and as a chair. It has a white plastic exterior with a gray tray with two cup holders, seat and a step. Manufacture codes included in this recall are 10-2020, 3-2021, and 5-2021 which can be found on the removable seat/step. Model number "4134" is molded into the bottom of the tower.
Key Safety Systems, Inc. (DBA Joyson) is recalling certain HPH-A curtain air bag inflators. Moisture introduced during the manufacturing process can cause corrosion inside the pressure vessel, causing the inflator to rupture.
Potential for a wire protrusion through the left heart vent catheter tip
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
This recall involves the model VP-33 blower fans sold under the B-Air® Brand and intended primarily for commercial use for remediation. The recalled blowers were manufactured before January 1, 2018. The recalled air mover, 1/3 horsepower fans were sold in blue, red or green in a neon yellow-colored box. The B-Air logo is on the vent and on the product label.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
The firm's contract manufacturer found positive environmental samples analyzed for Listeria and Salmonella species.