Medline Recalls Medical Devices Manufactured Using Stryker-Recalled Smoke Evacuation Components
Medline is recalling 102,561 medical convenience items manufactured using SafeAir Smoke Evacuation Pencils that Stryker previously recalled, 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: This is an FDA Class II recall of products manufactured using a recalled component. No specific hazard, injury, or illness is described in available recall information, and the underlying reason for Stryker's recall is not specified. The recall appears precautionary in nature.
Plain-English summary
Medline Industries, LP is recalling medical convenience items that were manufactured using SafeAir Smoke Evacuation Pencils produced by Stryker. Stryker recalled the SafeAir Smoke Evacuation Pencil, prompting Medline to initiate a corresponding recall of all products manufactured with this recalled component. The recall affects approximately 102,561 units that were distributed nationwide.
The affected Medline products are identified by multiple reference catalog numbers and specific lot numbers listed in the recall documentation. Healthcare providers and facilities should reference these product identifiers to determine whether they have received affected units.
Medialine initiated the recall in response to Stryker's recall of the SafeAir Smoke Evacuation Pencil component. For more information about affected products and instructions on product handling, return, or replacement, healthcare facilities should contact Medline Industries.
The recalled product
- Product
- Refer to RES or lead review memo for complete list of affected reference/catalog numbers
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 102,561
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 CDS780147M
- UDI/DI 10193489445510 (each) 40193489445511 (case)
- Lot Numbers: 22EBM611
- 22EBO511
- 2) REF CDS860040K
- UDI/DI 10195327010447 (each) 40195327010448 (case)
- Lot Numbers: 22ELA276
- 23ALB139
- 23ELA269
- 23CLB184
- 22JLA300
- 3) REF CDS980245X
- UDI/DI 10193489848434 (each) 40193489848435 (case)
- Lot Numbers: 22GBS312
- 22FBG764
- 22KBJ856
- 23BBG738
- 4) REF CDS980566F
- UDI/DI 10193489445442 (each) 40193489445443 (case)
- Lot Numbers: 22HBJ660
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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