Z-0527-2026Class II
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-09-30 / Open, Classified
Medline Industries, LP began a recall of MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0527-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.
- Product code
- OJF Hysterectomy Kit
- 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.
- FDA root cause
- Under Investigation by firm
- Action
- 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 [email protected].
- Quantity in commerce
- 570 kits
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 23DDC245, 23GDC219; 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers: 24LMF192; 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 24BBR389, 24CBH709; 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers: 23EDB911, 23FDC315, 23HDA180; 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100; 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287; 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682; 8) REF DYNJ50315F: UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers: 23KMF190; 9) REF DYNJ60554B: UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers: 23EBD224, 23KBE886; 10) REF DYNJ67194B: UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23HBN435; 11) REF DYNJ900298L: UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers: 23LBF269, 23LBT933, 24BBT248; 12) REF DYNJ900721C: UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 23HBW996; 13) REF PHS396954006G: UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers: 23HDB088; 14) REF PHS396975006F: UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers: 23JDB593.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0511-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0512-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0513-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0514-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0515-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0516-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0517-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0518-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0519-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0520-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0521-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0522-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0523-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0524-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0525-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0526-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0527-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0528-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0529-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0530-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.