Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- REF
- CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case)
- Lot #
- 23FBP157
- REF
- CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case)
- Lot #
- 23GBM569
- REF
- CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case)
- Lot #
- 23LBN523
- REF
- CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case)
- Lot #
- 24BBA266
- REF
- CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case)
- Lot #
- 24CBS676
- REF
- CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case)
- Lot #
- 24EBM454
- REF
- DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case)
- Lot #
- 23HMA639
- REF
- DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case)
- Lot #
- 23HMF507
- REF
- DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case)
- Lot #
- 23GMI327
- REF
- DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case)
- Lot #
- 23JMC006
- REF
- DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case)
- Lot #
- 23LMA065
- REF
- DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case)
- Lot #
- 23LMC367
- REF
- DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case)
- Lot #
- 24DMF699
- REF
- DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case)
- Lot #
- 24EMA236
- REF
- DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case)
- Lot #
- 23GBI654
- REF
- DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case)
- Lot #
- 23GBJ925
- REF
- DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case)
- Lot #
- 23HBZ090
- REF
- DYNJ33977M: UDI/DI 10195327422523 (each), 40195327422524 (case)
- Lot #
- 23HBB046
- REF
- DYNJ44852M: UDI/DI 10195327325220 (each), 40195327325221 (case)
- Lot #
- 23HME689
- REF
- DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case)
- Lot #
- 23GBA730
- REF
- DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case)
- Lot #
- 23HBG731
- REF
- DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case)
- Lot #
- 23HBT208
- REF
- DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case)
- Lot #
- 23IBG463
- REF
- DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case)
- Lot #
- 23KMI230
- REF
- DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case)
- Lot #
- 24BME250
- REF
- DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case)
- Lot #
- 24DME657
- REF
- DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case)
- Lot #
- 23LMB473
- REF
- DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case)
- Lot #
- 24AMH995
- REF
- DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case)
- Lot #
- 24EMA379
- REF
- DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case)
- Lot #
- 23DMG612
- REF
- DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case)
- Lot #
- 23JMD696
- REF
- DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case)
- Lot #
- 23IMG461
- REF
- DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case)
- Lot #
- 24BMC283
- REF
- DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case)
- Lot #
- 23LBN305
- REF
- DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case)
- Lot #
- 24CBE964
- REF
- DYNJ68464B: UDI/DI 10195327666224 (each), 40195327666225 (case)
- Lot #
- 24DBP960
- REF
- DYNJ83856: UDI/DI 10195327318253 (each), 40195327318254 (case)
- Lot #
- 23GBV076
- REF
- DYNJ83856A: UDI/DI 10195327520830 (each), 40195327520831 (case)
- Lot #
- 23LBD001
- REF
- DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case)
- Lot #
- 24CBA468
- REF
- DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case)
- Lot #
- 24CBJ818
- REF
- DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case)
- Lot #
- 24EBC307
- REF
- DYNJ84332A: UDI/DI 10198459022432 (each), 40198459022433 (case)
- Lot #
- 24EMI031
- REF
- DYNJ85111: UDI/DI 10195327460808 (each), 40195327460809 (case)
- Lot #
- 23JBC629
- REF
- DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case)
- Lot #
- 24CBI707
- REF
- DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case)
- Lot #
- 24EBP322
- REF
- DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case)
- Lot #
- 24IBK581
- REF
- DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case)
- Lot #
- 24BBI057
- REF
- DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case)
- Lot #
- 24CBA316
- REF
- DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case)
- Lot #
- 24DBS660
- REF
- DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case)
- Lot #
- 23KBW113
- REF
- DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case)
- Lot #
- 24BBA200
- REF
- DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case)
- Lot #
- 24CBG796
- REF
- DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case)
- Lot #
- 24CBL477
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 23HBA138
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 23LBP102
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 24ABO369
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 24BBO672
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 24CBL486
- REF
- DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case)
- Lot #
- 24DBM827
- REF
- DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case)
- Lot #
- 23EBN537
- REF
- DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case)
- Lot #
- 23EBT257
- REF
- DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case)
- Lot #
- 23LBK712
- REF
- DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case)
- Lot #
- 24DBV324
- REF
- DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case)
- Lot #
- 24CBI553
- REF
- DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case)
- Lot #
- 24DBI370
- REF
- DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case)
- Lot #
- 24ABK735
- REF
- DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case)
- Lot #
- 24DBR411
- REF
- DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case)
- Lot #
- 23FMB748
- REF
- DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case)
- Lot #
- 23FMI603
- REF
- DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case)
- Lot #
- 23LMH380
- REF
- DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case)
- Lot #
- 24BMG608
- REF
- DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case)
- Lot #
- 24DMD838
- REF
- DYNJ910440: UDI/DI 10195327685973 (each), 40195327685974 (case)
- Lot #
- 24EBJ004
- REF
- DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case)
- Lot #
- 23KMI086
- REF
- DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case)
- Lot #
- 23LMH856
- REF
- PHS397064007D: UDI/DI 10195327454111 (each), 40195327454112 (case)
- Lot #
- 23HDB143
Show 142 more code fieldsShow fewer
What the firm is doing
Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions: 1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form. 3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. For distributors or those who have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0519-2026
- FDA device classification · FTNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.3925The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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