MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF — Class II medical device recall Z-0519-2026
Ongoing recall by Medline Industries, LP, reported 2025-11-26, distributed nationwide. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir
| Recall number | Z-0519-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 4,214 kits |
| UPC / GTIN / UDI-DI | 10193489288872, 10193489968644, 10195327125424, 10195327185237, 10195327208127, 10195327243470, 10195327247584, 10195327261665, 10195327318253, 10195327325220, 10195327329136, 10195327338473, 10195327351533, 10195327363512, 10195327371449, 10195327418649, 10195327418717, 10195327421410, 10195327422523, 10195327439859, 10195327450434, 10195327454111, 10195327460808, 10195327520830, 10195327529857 and 39 more |
| Lot numbers | 23DMG612, 23EBN537, 23EBT257, 23FBP157, 23FMB748, 23FMI603, 23GBA730, 23GBI654, 23GBJ925, 23GBM569, 23GBV076, 23GMI327, 23HBA138, 23HBB046, 23HBG731, 23HBT208, 23HBZ090, 23HDB143, 23HMA639, 23HME689, 23HMF507, 23IBG463, 23IMG461, 23JBC629, 23JMC006, 23JMD696, 23KBW113, 23KMI086, 23KMI230, 23LBD001, 23LBK712, 23LBN305, 23LBN523, 23LBP102, 23LMA065, 23LMB473, 23LMC367, 23LMH380, 23LMH856, 24ABK735 and 36 more |
| Model numbers | CDS983639K, CDS984267J, DYNJ00264M, DYNJ0428947L, DYNJ0428947M, DYNJ27319V, DYNJ33977M, DYNJ44852M, DYNJ57527C, DYNJ58257G, DYNJ58668D, DYNJ66495A, DYNJ67968B, DYNJ68464A, DYNJ68464B, DYNJ83856, DYNJ83856A, DYNJ83856B, DYNJ84332A, DYNJ85111, DYNJ900294L, DYNJ904966C, DYNJ906638B, DYNJ907141B, DYNJ907791B and 7 more |
Product
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC PACK, REF DYNJ83856A; 18) PLASTIC PACK, REF DYNJ83856B; 19) BREAST PACK, REF DYNJ84332A; 20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111; 21) BREAST-CHEST, REF DYNJ900294L; 22) PLASTICS MASTECTOMY, REF DYNJ904966C; 23) BREAST PLASTIC, REF DYNJ906638B; 24) BREAST-CHEST, REF DYNJ907141B; 25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B; 26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D; 27) BREAST HERNIA, REF DYNJ908058A; 28) CHEST BREAST KIT, REF DYNJ909203A; 29) PLASTIC, REF DYNJ909410; 30) PLASTIC, REF DYNJ910440; 31) BREAST -LF, REF DYNJ9426113N; 32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D.
Reason for recall
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.
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-0519-2026. 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.