Medline Surgical Convenience Kits Recalled Over Supplier Component Recall
Medline is recalling 336 surgical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that Stryker previously recalled. The kits were distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. This is a precautionary recall initiated due to a supplier's recalled component, and the specific hazard of the SafeAir Smoke Evacuation Pencil is not disclosed in this notice.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits due to the use of SafeAir Smoke Evacuation Pencil components that were previously recalled by manufacturer Stryker. These recalled products include lithotomy/pelviscopy packs with specific reference numbers and associated lot numbers, with a total of 336 units distributed nationwide.
The recalled products include three types: Lithotomy/Pelviscopy Pack (REF DYNJ0531985R) with lot numbers 22HMF853, 23CMA603, and 22LMG691; Pelviscopy Pack-LF (REF DYNJ0843760I) with lot number 23DDA645; and Pelviscopy Pack-LF (REF DYNJ0843760J) with lot number 23JDA821.
Healthcare facilities and consumers should discontinue use of these kits and contact Medline regarding return procedures. The specific defect or hazard associated with the recalled SafeAir Smoke Evacuation Pencil component has not been detailed in this recall notice. For additional information, consult the FDA recall notice or contact Medline directly.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 336
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 (11)
- 1) REF DYNJ0531985R
- UDI/DI 10195327216405 (each) 40195327216406 (case)
- Lot Numbers: 22HMF853
- 23CMA603
- 22LMG691
- 2) REF DYNJ0843760I
- UDI/DI 10195327365141 (each) 40195327365142 (case)
- Lot Numbers: 23DDA645
- 3) REF DYNJ0843760J
- UDI/DI 10195327491369 (each) 40195327491360 (case)
- Lot Numbers: 23JDA821
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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