MEDLINE Surgical Convenience Kits Recalled Due to Defective Smoke Evacuation Equipment
Medline is recalling surgical convenience kits that contain defective smoke evacuation pencils previously recalled by Stryker. The 478 affected units were distributed nationwide; healthcare facilities should discontinue use immediately and contact Medline for instructions.
What this means for you
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: This is a Class II medical device recall affecting surgical convenience kits used in invasive procedures. Although no illnesses or injuries have been reported, these products are inherently risk-of-harm devices, and defective surgical components could impair function during critical procedures.
Plain-English summary
Medline is recalling multiple surgical convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were subsequently recalled by Stryker. The affected kits include obstetric/gynecological lithotomy packs, general lithotomy packs, laparoscopy packs, and dilation and curettage (D&C) packs.
A total of 478 units were affected and distributed nationwide throughout the United States. Healthcare facilities and surgical centers that have received these kits should identify affected units using the reference numbers and lot numbers provided in the FDA recall notice and discontinue use of the recalled kits immediately.
Users and healthcare providers should contact Medline for further instructions regarding the recalled kits, including options for return or replacement. The recall is classified as FDA Class II and affects various product reference numbers with specific lot numbers detailed in the official FDA recall notice.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PAC
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- equipment-defect
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 CDS985431J
- UDI/DI 10195327336110 (each) 40195327336111 (case)
- Lot Numbers: 23BBG608
- 2) REF CDS985431K
- UDI/DI 10195327451295 (each) 40195327451296 (case)
- Lot Numbers: 23JBF512
- 23IBQ647
- 3) REF CDS985431L
- UDI/DI 10195327527273 (each) 40195327527274 (case)
- Lot Numbers: 24ABA205
- 24ABW239
- 24ABV349
- 24CBR704
- 24EBP485
- 4) REF DYNJ44153G
- UDI/DI 10195327412623 (each) 40195327412624 (case)
- Lot Numbers: 23KBB932
- 5) REF DYNJ60924C
- UDI/DI 10195327470333 (each) 40195327470334 (case)
- Lot Numbers: 23JBF913
Distribution
Distributed nationwide across the United States.
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