Medline Surgical Convenience Kits Recalled for Defective Component
Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.
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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, prompted by a recalled component from another manufacturer. The specific defect in the smoke evacuation pencil is not detailed in the notice.
Plain-English summary
Medline Industries is recalling six models of surgical convenience kits distributed in the United States. The affected products are labeled as Vaginal, Day Surg Large Vag Cds, Major Vaginal Pack-Lf, Vaginal Pack, Vaginoplasty Pack, and ACH Major Vaginal Pack. Each product variant has distinct reference numbers and UDI codes.
The kits are being recalled because they contain SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The recall encompasses 1,952 units distributed nationwide, with specific lot numbers identified for each product variant.
Healthcare facilities and users in possession of these kits should verify their product reference numbers and lot numbers against the FDA recall notice. Contact Medline Industries for guidance on return, replacement, or credit of affected units. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Hazard
- Affected units
- 1,952
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)
- 1) REF CDS984955M
- UDI/DI 10195327313302 (each) 40195327313303 (case)
- Lot Numbers: 23CBU078
- 23HBG687
- 23IBF280
- 2) REF CDS984995M
- UDI/DI 10195327043766 (each) 40195327043767 (case)
- Lot Numbers: 22GBA249
- 23ABF616
- 23ABF770
- 23EBG938
- 23CBD779
- 23GBH707
- 23KBU446
- 23IBE467
- 3) REF DYNJ0826768P
- UDI/DI 10193489265699 (each) 40193489265690 (case)
- Lot Numbers: 22FMC589
- 22DMI812
- 23AMG530
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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