One injectable supplier's quality problem became 94 recalls across 7 companies — the consequence of packing components into kits (Arrow International)
The U.S. Food and Drug Administration classified Arrow International procedure kits as Class I — its most serious category — because the lidocaine, bupivacaine, and 0.9% sodium chloride packed into them were the subject of a supplier recall. Across our collected data, that upstream event runs to 94 enforcement records spanning seven companies, 59 of them Class I.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmARROW INTERNATIONAL, LLC
- ReasonLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- DistributionUS Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY...
- Recall initiated2026-04-21
Key points
- Recall number Z-2379-2026; FDA Class I, the most serious category; status Ongoing; quantity 1,516.
- The reason is that lidocaine, bupivacaine, and 0.9% sodium chloride subject to a supplier recall were included in kits and sets.
- The reason states the supplier's quality issues, limited reports of drug ineffectiveness, and serious injury if sterility is compromised.
- Within our collection, 94 enforcement records state a supplier-recall origin, spanning seven firms: 59 Class I and 35 Class II.
- The split is Arrow International 29 / Medline 25 / Avanos 20 / Becton Dickinson 10 / Argon Medical 6 / B. Braun 3 / Spectra Medical 1.
- Across the 1,408 FDA recall records this site holds as of 2026-09-01 the reason texts reduce to 534 wordings, the most shared covering 29 records — the injectable at issue here.
1What a procedure kit is as a product
Most procedures in a hospital begin by opening a kit that gathers the necessary items together. Needles, catheters, drapes, antiseptics, and local anesthetic — everything one procedure requires, arranged in a pouch or tray, ready the moment it is opened. It removes preparation work and reduces mix-ups, with the side effect that the company assembling the kit and the companies making its contents are different.
The name printed on the kit therefore belongs to the assembler, and the company that made the failing component does not appear on it at all.
2One supplier's problem spreading across seven firms
Counting the enforcement records in our collection whose reason states that it derives from a supplier recall gives 94 records across seven companies: Arrow International (29), Medline (25), Avanos (20), Becton Dickinson (10), Argon Medical (6), B. Braun (3), and Spectra Medical (1). They were reported between 2026-06-03 and 2026-08-19, comprising 59 Class I and 35 Class II records.
Read one at a time they look like separate corporate recalls; laid side by side they are one event spreading from a single point upstream.
3Why "ineffectiveness" and "sterility" appear together
The reason for this recall states three things at once: that the supplier was found to have quality issues, that there were limited reports of drug ineffectiveness, and that a compromise of sterility in a water-based injectable could lead to serious or life-threatening injury. If a local anesthetic does not work, the procedure hurts; if it is not sterile, it can infect.
The same quality problem in the same product generates two hazards of entirely different kinds.
4The largest group sharing one reason text runs to 29
Across the 1,408 FDA recall records this site holds as of 2026-09-01, the reason texts reduce to 534 distinct wordings. The single wording shared by the most records covers 29 of them, and it is the one about the injectable at issue here.
When a problem at one supplier spreads to the products of every company that packed it, the records multiply by the number of companies. Different numbers, different firm names — in a list they look unrelated. Only lining up the reason texts shows that it was one event.
Why it matters
In a procedure-kit supply chain only the assembler's name is visible, so how many downstream recalls one upstream problem produces is hard to see from outside. Hospital inventory checks therefore have to work at the level of components, not just product names. In an event spanning seven firms and 94 records, the load of receiving each company's notice separately is also considerable, and whether stock can be queried by component decides the pace of the response.
FAQ
Why do many companies recall over one problem?
Can the kit name tell me whether I am affected?
Are the figures of 94 records and seven firms published by the FDA?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2379-2026