One component recall spreads into 18 records — particulate in a manifold pulled the surgical kits built around it into recall one after another
Convenience kits for cardiac catheterization sold by AVID Medical were recalled because of the recall of the Medline angiographic manifolds inside them. Particulate within the fluid path of the manifolds has the potential to enter blood circulation and lodge within blood vessels. Classification is Class I and 5,168 kits are covered.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmAVID Medical, Inc.
- ReasonAffected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
- DistributionUS Nationwide distribution in the states of NC and TX.
- Recall initiated2026-04-30
Key points
- AVID Medical cardiac catheterization convenience kits were recalled because of the recall of the Medline manifolds inside them.
- Particulate within the fluid path of the manifolds has the potential to enter blood circulation and lodge within blood vessels.
- 5,168 kits are covered, classification is Class I, and recall initiation was 2026-04-30, with U.S. distribution to NC and TX.
- Of the records this site holds as of 2026-09-02, 18 mention a manifold in the recall reason — one component recall becoming separate records at each stage of the chain.
- Counting reasons among the same 1,408 records: sterility and microbial contamination 353, undeclared allergens 109, CGMP deviations 75, particulate 49.
1A recall where the product itself is not the fault
Read enough recall records and you meet ones triggered not by a defect in the product but by the recall of a component built into it. This is one.
What was recalled is a convenience kit for cardiac catheterization, but the fault lies with a manifold inside it — the device that switches the flow path for contrast medium and saline — where particulate within the fluid path has the potential to enter blood circulation and lodge within blood vessels.
2How many records one cause produces
Kits containing the same component are assembled by several companies under several part numbers, and each becomes a separate recall record. Among the records this site holds, 18 mention a manifold in the recall reason. When counting recalls, whether a figure represents 18 separate problems or 18 expressions of one problem cannot be told without reading the reason text.
3A recall travelling back up the supply chain
A medical convenience kit gathers the instruments used in a procedure into one sterile package. The assembler sources many components externally, and if one of them proves faulty the finished kit falls under recall too. The same root cause is then recorded separately at each stage of the chain — component maker, kit assembler, and the party that sells it.
4As a matter of reading the records
Of the 1,408 FDA recall records this site holds as of 2026-09-02, devices lead at 779, followed by food at 341 and drugs at 288. Counting the words that appear in recall reasons, sterility and microbial contamination lead at 353, undeclared allergens at 109, CGMP deviations at 75 and particulate at 49. This case belongs to the particulate type.
For products in use, follow healthcare professionals and the official information from the FDA and the manufacturer.
Why it matters
When counting recalls, the number of independent events and the number of records one cause generates along a supply chain must be told apart. It also shows how, in kit manufacturing, traceability of sourced components determines how fast the scope of a recall can be pinned down.
FAQ
Was the kit itself defective?
Why do several records share one cause?
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-2798-2026