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LapPakOR

THE O R COMPANY PTY LTD · Model W-18 · UDI-DI 09349967000700

GCZ Prescription
5
510(k) clearances
39
Adverse events
6
Recalls
50
Facilities

Description

Single piece bowel retractor

Recalls

DateFirmReason
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.