Regulatory Updates
Sep 3, 2026•1 min read
Balt Extrusion Voluntarily Recalls ANRYV Connectors Over Bacterial Endotoxin Test Failure
Balt Extrusion is voluntarily recalling specific ANRYV connector lots after non‑conforming bacterial endotoxin test results, affecting standalone connectors and those in selected kits; no patient harm reported.
Regulatory Updates
Sep 2, 2026•1 min read
Olympus Recalls BiCOAG Hemostasis Probe Over Adhesive Defect
Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to possible adhesive shortage causing ceramic tip detachment.
Regulatory Updates
Sep 2, 2026•1 min read
Samchundang Pharma receives manufacturing suspension over test record violations and recall plan failure
Samchundang Pharmaceutical was ordered to halt production after the MFDS found irregularities in a potency test and a failure to submit a recall plan for its contracted Lefurozin syrup.
Regulatory Updates
Sep 1, 2026•1 min read
South Korea's MFDS orders recall of Daewoong and YS Life Science medicines over packaging label mismatch
The Ministry of Food and Drug Safety has recalled specific batches of Daewoong Pharmaceutical’s ezetimibe/rosuvastatin tablets and products from YS Life Science due to packaging label discrepancies.
Regulatory Updates
Aug 31, 2026•1 min read
Health Canada Recall: JAMP Temozolomide 140 mg Capsules Out of Specification
Health Canada has issued a retail recall of JAMP Temozolomide 140 mg capsules (lot RLTS0225A) because the active ingredient temozolomide is out of specification.
Regulatory Updates
Aug 30, 2026•1 min read
Unexpected Shutdown of Carestation 850 Anesthesia Systems When AC Power Is Lost
Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.
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Regulatory Updates
Aug 30, 2026•1 min read
Unexpected Shutdown Risk for Carestation 850/850C Anesthesia Systems
Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.
Regulatory Updates
Aug 30, 2026•1 min read
Gentherm Medical Reports Overheated Circuit Boards in Blanketrol Devices
Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS orders recall of Il Dong Pharma's Consenvita Premium 800 tablets due to labeling omissions
The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.
Regulatory Updates
Aug 30, 2026•1 min read
Amgen Initiates Voluntary Recall of ~1M Bottles of Corlanor in US
Amgen voluntarily recalls about 1 million bottles of its heart‑failure drug Corlanor in the US after potential foreign particles were identified.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Recall Issued Due to Lack of Assurance of Sterility
The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.
Regulatory Updates
Aug 30, 2026•1 min read
Abiomed Voluntary Recall of Automated Impella Controllers in Canada Over Purge Flag Issues
Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag component failures that can affect device performance.