Recall record at a glance
| Official record | Z-0524-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medline Industries, LP |
| Report date | Nov 26, 2025 |
| Recall initiation date | Sep 30, 2025 |
| Quantity | 2844 kits |
| Location | Northfield, IL, United States |
Official product description
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF DYNJ907910B; 20) GP-ROBOTIC PACK-LF, REF PHS504647004G.
Why the product was 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.
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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