MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
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: These medical devices are used in invasive surgical procedures and contain components from a Stryker-recalled product, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' The FDA Class II classification confirms elevated health risk, though no reported illnesses or injuries are documented in the source.
Plain-English summary
MEDLINE Industries is recalling surgical convenience kits that contain smoke evacuation pencil components sourced from Stryker products that were previously recalled. These convenience kits are used in gynecological, robotic, urological, and general surgical procedures. The recall was initiated due to the presence of defective components in the kits.
A total of 73 different surgical kit models are affected, with approximately 13,057 units distributed nationwide. Each kit model has been identified by specific reference numbers and lot numbers for tracking purposes. The affected products were distributed throughout the United States.
Consumers and healthcare facilities should immediately discontinue use of any affected kits and contact MEDLINE Industries for instructions on returns, replacements, or other remedies. To determine if a kit is included in this recall, verify the product reference number and lot number on the packaging against the detailed list provided in the official FDA recall notice. Additional information and assistance can be obtained by contacting MEDLINE Industries directly.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 13,057
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)
- 85OHD
- 1) REF CDS760059I
- UDI/DI 10195327009526 (each) 40195327009527 (case)
- Lot Numbers: 22KBT168
- 22GBJ110
- 22FBO228
- 22FBN206
- 23ABM526
- 2) REF CDS920099S
- UDI/DI 10195327140656 (each) 40195327140657 (case)
- Lot Numbers: 22EBA153
- 23HBS831
- 23GBT006
- 23ABF835
- 23ABE852
- 23ABC459
- 22IBE827
- 22GBP098
- 3) REF CDS980998L
- UDI/DI 10193489232837 (each) 40193489232838 (case)
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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