Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1267-2019 — Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a locat

U.S. FDA — Device Enforcement · United States · 2019-04-11 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1267-2019
Date of alert: 2019-04-11
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Ethicon Endo-Surgery Inc
Product category: device
Product type: Devices

Reported risk: The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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