Recall StatusOpen, Classified
Date Initiated2025-12-05
Product Quantity33 units
Reason for Recall
Incorrect expiration date
Firm Action
On December 11, 2025, Stryker ( LimFlow Inc.) issued a Urgent Medical Device Recall Notification letter. Stryker ask consignees to take the following actions:
1. Immediately check your internal inventory to locate the product(s) listed on the attached Business Reply Form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use.
2. Sign and return the enclosed Business Reply Form by email to to confirm receipt of this notification/documenting product segregation.
3. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return and replacement of your product(s).
4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AL, CT, District of Columbia, FL, KY, MA, MI, NE, NJ, NY, OH, PA, RI, TX, WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.