Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Medical device recall Z-0635-2025. Published in FDA’s Enforcement Report on Dec 11, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 11, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 102561 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
102561 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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;…
Every code shown here, 1,996 characters
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, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 40193489402774 (case), Lot Numbers: 22GBT396; 15) REF CDS983914K, UDI/DI 10193489402698 (each) 40193489402699 (case), Lot Numbers: 22EBA061, 22DBU743, 22GBI220; 16) REF CDS984599F, UDI/DI 10193489486148 (each) 40193489486149 (case), Lot Numbers: 22EMH743, 22HMA205, 22GMB332, 22KMF120, 22KMF139, 22HMF967, 23FME358, 23AMI307, 22LMF801, 23GMB934, 23KMF368, 23LMC668; 17) REF CDS984600F, UDI/DI 10193489486100 (each) 40193489486101 (case), Lot Numbers: 22JME533, 22HMH038,…
FDA’s list runs to 36,618 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 9, 2024.
- FDA classified it on Dec 5, 2024.
- FDA’s Enforcement Report published it on Dec 11, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 36,618 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.