Medline surgical kits recalled for non-conforming cannula components
Medline is recalling 6,069 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves surgical kits with cannula components that may leak or break during use, a risk-of-harm product where the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 6,069 surgical convenience kits distributed nationwide in the United States. The affected products include various spinal, craniotomy, laminectomy, and other surgical packs, identified by specific Medline Product Numbers/SKUs and lot numbers listed in the recall notice.
The recall was initiated because the kits contain cannula components that do not conform to ISO 80369-7 dimensional requirements. This non-conformance may contribute to the components leaking or breaking during use. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries, LP for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 6,069
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Product Number/SKU CDS940087AM
- UDI/DI 10198459311499 (each) 40198459311490 (case)
- Lot Number 26DMG028
- Lot Number 26DMF181
- Lot Number 26DMD186
- Lot Number 26CMA323
- Lot Number 26BMJ234
- Medline Product Number/SKU DYNJ907697C
- UDI/DI 10195327697617 (each) 40195327697618 (case)
- Lot Number 26ALA854
- Medline Product Number/SKU DYNJ0159820F
- UDI/DI 10193489207057 (each) 40193489207058 (case)
- Lot Number 26ADB485
- Lot Number 26ADA395
- Medline Product Number/SKU DYNJ67139D
- UDI/DI 10195327668273 (each) 40195327668274 (case)
- Lot Number 26ABM111
- Medline Product Number/SKU CDS780025AD
- UDI/DI 10198459311598 (each) 40198459311599 (case)
- Lot Number 25LBH825
Distribution
Distributed nationwide across the United States.
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