Severity
Moderate
MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on December 11, 2024. Classified as Moderate severity (Class II). Approximately 58765 units units are affected. The recall was issued because: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-0645-2025) was formally reported on December 11, 2024, with the manufacturer initiating the action on October 9, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 58765 units units are affected.
The documented reason for this recall is: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Moderate
Units Affected
58765 units
Related Recalls
6
6 from same agency
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0645-2025 |
| Date reported | December 11, 2024 |
| Date initiated | October 9, 2024 |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Units affected | 58765 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).