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

Recall Z-0796-2025 — SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

U.S. FDA — Device Enforcement · United States · 2024-11-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0796-2025
Date of alert: 2024-11-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Med Michigan Holding Llc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00817278010514

Reported risk: Incomplete or partial pouch seals, which may result in a breach in the sterility.

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.

Recall Z-0796-2025 — SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

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