CLASS II Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
SCD Comfort Knee Length Small recalled by Cardinal Health 200
Cardinal Health 200 is recalling SCD Comfort Knee Length Small, distributed nationwide in the US. 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-1917-2025
- 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
SCD Comfort Knee Length Small, SKU 84021; 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
Is SCD Comfort Knee Length Small recalled?
Yes. Cardinal Health 200 recalled SCD Comfort Knee Length Small on 13 May 2025. The recall is Class II and its status is Completed. Recall number Z-1917-2025.
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) 50885380186514 (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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |