Halyard CATH LAB Kit Recall Issued by AVID Medical
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AVID Medical, Inc. is recalling 172 Halyard CATH LAB kits (model SACL75-01) distributed to seven U.S. states due to a potential syringe disconnection hazard.
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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard CATH LAB kits after identifying a potential risk that the Medline syringe rotating adaptor may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold.
Which Products Are Affected
The recall covers 172 kits of the Halyard CATH LAB kit, model number SACL75-01. Affected UDI (Kit Lot Numbers) include: (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), and (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863). Distribution was limited to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.
What You Should Do
The recall was initiated voluntarily by the firm via email on March 13, 2026. Customers with affected products should follow instructions provided by AVID Medical, Inc.
Why This Matters
This is an FDA Class I recall, indicating a reasonable probability of serious adverse health consequences from the potential device disconnection during use.
Source
FDA Enforcement Report, recall number Z-1974-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
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