FDA Recall of FLEXTIP PLUS Epidural Catheter Announced
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ARROW INTERNATIONAL, LLC is recalling 190 units of the FLEXTIP PLUS Epidural Catheter due to a manufacturing issue with the liquid adhesive, affecting devices distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" 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.
Recall Article
What Happened
ARROW INTERNATIONAL, LLC is recalling certain epidural catheters after receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured. This is a voluntary recall initiated by the firm.
Which Products Are Affected
The affected products include the FLEXTIP PLUS EPIDURAL CATHETER and FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET, with reference number ASK-05502-BSM. The UDI code is (01)10801902209853(17)270831(11)251210(10)33F25K0409, and the batch number is 33F25K0409. A total of 190 units are affected, distributed in the U.S. states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. The recall number is Z-1913-2026.
What You Should Do
Consumers should contact ARROW INTERNATIONAL, LLC for instructions on returns or refunds. The firm can be reached at their address: 3015 Carrington Mill Blvd, Morrisville, NC 27560-5437, as the initial notification was made via letter.
Why This Matters
This recall involves medical devices used for epidural anesthesia, potentially affecting patient safety due to the manufacturing defect. It highlights the importance of quality control in medical supplies, with 190 units impacted across multiple states.
Source
Information from FDA recall notice Z-1913-2026. Attribution: FDA (U.S. Food and Drug Administration).
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 (1,340 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.