Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 26, 2025
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 BR
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP recalled MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) B… - a moderate-severity action.
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) B… was recalled by Medline Industries, LP in November 26, 2025. Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir…. Check the official notice for the remedy. Verify recall #Z-0519-2026 with the FDA Devices before acting.
The recall
Medline Industries, LP issued this moderate-severity FDA Devices recall-Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir….
- Moderate
- severity level
- Class II
- classification
- November 26, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0519-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0519-2026) was formally reported on November 26, 2025, with the manufacturer initiating the action on September 30, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 4214 kits.
The documented reason for this recall is: 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 Evacuat… 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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices and 2 from Medline Industries, LP - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4214 kits
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0519-2026 |
| Date reported | November 26, 2025 |
| Date initiated | September 30, 2025 |
| Recalling firm | Medline Industries, LP |
| Firm location | Northfield, IL |
| Affected scope | 4214 kits |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0519-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medline Industries, LP. Units affected: 4214 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0519-2026.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0519-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.