Z-0524-2026Class II
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-09-30 / Open, Classified
Medline Industries, LP began a recall of 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)... 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-0524-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- 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.
- Product code
- OHD Gynecological Laparoscopic 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
- 2844 kits
- Distribution
- US Nationwide distribution.
- Product codes and lots
- REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 23LBV707; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD429; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD498; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24DBK836; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24HBE577; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23HBO463; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23JBF467; REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 24ABP835; REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case), Lot Numbers: 24CBK422; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23GBT512; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23HBI619; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23LBN095; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24BBR322; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBA027; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBT103; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24EBG556; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23GBO806; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23HBJ772; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23EDB052; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB708; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB759; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23DBJ363; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23EBU559; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23HBL687; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23JBD927; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 23LBG811; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 24BBQ970; REF DYNJ64234C: UDI/DI 10195327486921 (each) 40195327486922 (case), Lot Numbers: 23JMA672; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23EMH332; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23HMB194; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBJ145; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBK217; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23FBS005; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23GBP632; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23IBP551; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23JBH964; REF DYNJ86154: UDI/DI 10195327598112 (each) 40195327598113 (case), Lot Numbers: 24CBA421; REF DYNJ900296K: UDI/DI 10195327554088 (each) 40195327554089 (case), Lot Numbers: 23LBG402; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBF280; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBO223; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24ABV771; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24CBC856; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24ABS777; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24BBB142; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24CBI705; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24EBN319; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC169; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC442; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMG251; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KMC642; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KME178; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23LMC669; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24ABT614; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24DBM183; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24EBJ705; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24ABC736; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24DBD770; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24EBH118; REF PHS504647004G: UDI/DI 10195327454142 (each) 40195327454143 (case), Lot Numbers: 23HDB026.
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.