FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF recall
- Recall number
- Z-0519-2026
- Date
- (initiated September 30, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4214 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
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 CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23FBP157; REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23GBM569; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 23LBN523; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24BBA266; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24CBS676; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24EBM454; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMA639; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMF507; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23GMI327; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23JMC006; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMA065; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMC367; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24DMF699; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24EMA236; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBI654; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBJ925; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40
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-0519-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.