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.

Recall Insight

This FDA Devices action (record #Z-0796-2025) was formally reported on January 8, 2025, with the manufacturer initiating the action on November 19, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Med Michigan Holding Llc is listed as the recalling firm, operating out of Walker, MI. Federal records indicate 109 boxes (2,180 eaches) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Incomplete or partial pouch seals, which may result in a breach in the sterility. Distribution data in the federal record shows the product reached: Product distributed to a distributor located in IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.