CLASS II Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Kendall SCD Blended Comfort Sleeves Knee Length Small recalled
Cardinal Health 200 is recalling Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow, distributed in Alaska, California, Florida, Massachusetts, Texas. The recall was initiated on 13 May 2025 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-1919-2025
- FDA event ID
- 96849
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 13 May 2025
- FDA classified
- 6 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 13 May 2025 | Recall initiated by company | |
| 6 Jun 2025 | Classified by FDA | +24 days |
| 18 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Where it was distributed
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Questions about this recall
Why was it recalled?
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Which lots are affected?
UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS
Where was it sold?
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
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
2 other products · FDA event 96849This product is part of a recall event; the main page for the event is SCD Comfort Knee Length Small recalled by Cardinal Health 200.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SCD Comfort Knee Length Small recalled by Cardinal Health 200 | Cardinal Health 200 | Device Malfunction | 5 states | |
| CLASS II | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric recalled | Cardinal Health 200 | Device Malfunction | 5 states |
More recalls from Cardinal Health 200
All 290| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs containing Medtronic Microstream Components recalled | Cardinal Health 200 | Device Malfunction | IL |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| 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 |