Olympus Corporation of the Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &…
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Read the official notice →- Date
- 2026-09-02
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation &…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of Kansas and Florida.…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
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US
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Other drugs & medical recalls in the United States
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Clorox Puerto Rico Recalls 6 Million Scented Mistolin and Lestoil Multi-Purpose Cleaners Due to Risk of Exposure to Bacteria
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GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
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