Halyard HEART CATH SELF REGIONAL Kit Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
AVID Medical, Inc. is recalling 2,932 Halyard HEART CATH, SELF REGIONAL kits due to a potential risk of syringe disconnection during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "high" 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, Devices.
What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard HEART CATH, SELF REGIONAL kits because of a potential risk for the Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Which Products Are Affected
- Product: Halyard HEART CATH, SELF REGIONAL kit
- Model Number: SELF131-05
- Quantity: 2,932 kits
- UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950)
- Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX
- Recall Number: Z-1975-2026
- Classification: Class I
- Recall Initiation Date: March 13, 2026
What You Should Do
Consumers in possession of the affected kits should follow guidance from the recalling firm or the FDA regarding the ongoing recall.
Why This Matters
This Class I recall involves a medical device where the potential disconnection poses a serious health risk during use.
Source
FDA recall Z-1975-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,130 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.