Recall record at a glance
| Official record | Z-0526-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medline Industries, LP |
| Report date | Nov 26, 2025 |
| Recall initiation date | Sep 30, 2025 |
| Quantity | 11032 kits |
| Location | Northfield, IL, United States |
Official product description
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C.
Why the product was recalled
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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