FDA Medical devices recall · November 26, 2025

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS recall

Read the official FDA notice ↗

Product

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 was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; REF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; REF DYNJ0536924U, UDI/

Distribution

US Nationwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0526-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.