MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF — Class II medical device recall Z-0646-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-11, distributed nationwide. Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil wh
| Recall number | Z-0646-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-09 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,452 units |
| UPC / GTIN / UDI-DI | 10193489437188, 10193489900309, 10193489915167, 10193489915730, 10193489915754, 10193489951608, 10193489983784, 10195327009656, 10195327046064, 10195327075613, 10195327083465, 10195327107727, 10195327107734, 10195327127565, 10195327127770, 10195327150273, 10195327150532, 10195327183264, 10195327183271, 10195327183288, 10195327183769, 10195327185121, 10195327185145, 10195327185169, 10195327196783 and 63 more |
| Lot numbers | 22DBL296, 22DBT480, 22EBB287, 22EBG378, 22EBO945, 22EBR089, 22FBL459, 22FBN014, 22FBR617, 22FBS033, 22FMH645, 22GBK158, 22GBO568, 22GBT650, 22GBY195, 22HBC445, 22HBE990, 22HDB535, 22HMF692, 22HMF864, 22IDA312, 22KBC673, 22KBW389, 22KDB315, 22KDB784, 22LBC401, 22LBC402, 22LBD142, 22LBE624, 22LBH130, 22LBP709, 22LDA249, 22LDA872, 22LDA975, 22LDB323, 22LDB908, 22LDB966, 22LDC130, 23ABM013, 23ABM839 and 83 more |
| Model numbers | CDS760056G, CDS983411J, CDS983497L, CDS984995N, DYNJ0160684F, DYNJ01921M, DYNJ0488471K, DYNJ0532873M, DYNJ0532873N, DYNJ0750737Q, DYNJ27434R, DYNJ33590I, DYNJ36628L, DYNJ36628M, DYNJ40623F, DYNJ44848L, DYNJ44863Q, DYNJ44900O, DYNJ44900P, DYNJ50047G, DYNJ61136D, DYNJ63371D, DYNJ63631A, DYNJ67194B, DYNJ67210A and 19 more |
Product
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0646-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.