Encore Medical Recalls EMPOWR Acetabular System Liners Due to Packaging Discrepancy
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Encore Medical, LP has voluntarily recalled 49 units of EMPOWR Acetabular System liners after discovering that packages may contain the incorrect medical device.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Encore Medical, LP has initiated a voluntary Class II recall of specific EMPOWR Acetabular System liners. The recall was triggered after a package labeled as a 942-01-40G acetabular system was found to contain a 942-01-36H acetabular system. The firm indicated that several other acetabular system and knee insert devices may also be affected by similar packaging discrepancies.
Which Products Are Affected
The recall involves 49 units of the EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+. The following specific models and lot numbers are affected:
- REF: 942-01-36H (36H); UDI-DI: 00190446309789; Lot: 624Z1032 (Exp: 03-15-2026)
- REF: 942-01-36J (36J); UDI-DI: 00190446309802; Lot: 626Z1021 (Exp: 03-15-2026)
- REF: 942-01-40G (40G); UDI-DI: 00190446309826; Lot: 628Z1034 (Exp: 03-15-2026)
- REF: 942-01-32C (32C); UDI-DI: 00190446309697; Lot: 615Z1026 (Exp: 03-15-2026)
These products were distributed in the following states and territories: Alabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, and Texas.
What You Should Do
Healthcare facilities and surgical centers should immediately inspect their inventory for the affected REF and Lot numbers. Any identified units should be quarantined to prevent use. Facilities should contact Encore Medical, LP at their Austin, Texas location (9800 Metric Blvd, Austin, TX 78758) for instructions on returning the affected products.
Why This Matters
Packaging discrepancies in medical devices can lead to significant surgical delays while staff work to exchange for the correct device. In some instances, such errors could potentially lead to revision surgery.
Source
This information is based on an official recall notification from the FDA. Recall Number: Z-1234-2026.
Original source: FDA Official Notice ↗
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