CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
Empowr Acetabular System: Liner, 10 degree Hooded, HXe+, 36H recalled
Encore Medical is recalling Empowr Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, distributed in 14 states. The recall was initiated on 5 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1234-2026
- FDA event ID
- 98177
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jan 2026
- FDA classified
- 2 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 5 Jan 2026 | Recall initiated by company | |
| 2 Feb 2026 | Classified by FDA | +28 days |
| 11 Feb 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Where it was distributed
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
AlabamaCaliforniaIowaMassachusettsMichiganMissouriMississippiNew JerseyNew YorkOklahomaPennsylvaniaPuerto RicoRhode IslandTexas
Questions about this recall
Why was it recalled?
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Which lots are affected?
REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026), 942-01-36J/00190446309802/626Z1021(03-15-2026), 942-01-40G/00190446309826/628Z1034(03-15-2026), 942-01-32C/00190446309697/615Z1026(03-15-2026)
Where was it sold?
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98177This product is part of a recall event; the main page for the event is Empowr 3D Knee Tibial Insert 5R, VE recalled by Encore Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Empowr 3D Knee Tibial Insert 5R, VE recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
More recalls from Encore Medical
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |