CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Halyard Cardiac Cath Pack SAN23CARDQ kit recalled by AVID Medical
Avid Medical is recalling Halyard Cardiac Cath Pack SAN23CARDQ kit, distributed in 7 states. The recall was initiated on 13 Mar 2026 and the FDA has classified it as Class I.
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-1971-2026
- FDA event ID
- 98686
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Mar 2026
- FDA classified
- 1 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Mar 2026 | Recall initiated by company | |
| 1 May 2026 | Classified by FDA | +49 days |
| 13 May 2026 | 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
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Product as listed by the FDA
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Where it was distributed
US distribution to FL, IL, MO, MS, NC, NE, TX.
FloridaIllinoisMissouriMississippiNorth CarolinaNebraskaTexas
Questions about this recall
Why was it recalled?
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Which lots are affected?
Model Number: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651).
Where was it sold?
US distribution to FL, IL, MO, MS, NC, NE, TX.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
9 other products · FDA event 98686This product is part of a recall event; the main page for the event is Halyard Cardiac Cath Tray Shands Jax kit recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Halyard Cardiac Cath Tray Shands Jax kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard VA Detroit Cath Lab Pack kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard CATH LAB kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard Cardiac Cath Pack kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard CATH LAB kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard Neuro IR Peripheral (PS 64405) kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard Heart Cath, Self Regional kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard Sammc Angiography kit recalled by AVID Medical | Avid Medical | Other | 7 states | |
| CLASS I | Halyard Perc Tray kit recalled by AVID Medical | Avid Medical | Other | 7 states |
More recalls from Avid Medical
All 184| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |