fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Medtronic MiniMed 770G Insulin Pump Recall Affects 95,704 Units Worldwide (2026)
Ambrosia Brands Rosabella Moringa Capsules Recalled for Salmonella Contamination (1,224,208 Units)
Product may be contaminated with Salmonella
Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall (2026)
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall 2026 — 6 Packaging Sizes
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
AvKARE Recalls Amantadine HCl Capsules Over Dissolution Issues
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Erbe USA Recalls 2,408 Flexible Cryoprobes for Surgery Over Rupture Risk (2026)
Probes may rupture/burst during activation
Erbe USA Recalls 5,154 Flexible Cryoprobes for Surgical Use Over Rupture Risk (2026)
Erbe USA recalled 5,154 Flexible Cryoprobes used in surgery after probes may rupture during activation. The defect can cause rupture or burst during activation. Stop using the device and follow recall instructions from the manufacturer.
Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus MAJ-1443/MAJ-1444 Endoscope Suction Valves Recalled in 2026
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Erbe USA Recall 33,390 Flexible Cryoprobes Over Rupture Risk (2026)
Probes may rupture/burst during activation
Olympus MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Burlington Medical Kilt Recall: 15,216 Units Worldwide Over Attenuation Degradation (2026)
Potential for attenuation degradation over time, decreasing the lifespan.
CareFusion 303 BD Alaris System with Guardrails Suite MX Recall Impacts 1,025,567 Units (2026)
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Burlington Medical Blockers Recalled for Attenuation Degradation in 51 Units Worldwide (2026)
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical Frontal Aprons Recalled for Attenuation Degradation in 2026 (14,323 Units)
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical Half Aprons Recalled for Attenuation Degradation Risk (2026)
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical Recalled 15,438 Radiation Attenuation Vests Over Degradation Risk (2026)
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical Kilt Blockers Recalled 94 Units Worldwide for Attenuation Degradation (2026)
Potential for attenuation degradation over time, decreasing the lifespan.
Waldemar Link Embrace Drill Tower Recall 74 Units in 2026
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.