Z-2431-2026Class II
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN... on . FDA classified it as Class II and gives the reason as "Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2431-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O
- Product code
- OHD Gynecological Laparoscopic Kit
- Reason for recall
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
- Quantity in commerce
- 49,654 kits total
- Distribution
- US Nationwide distribution. OUS distribution pending.
- Product codes and lots
- DYNJ905836D UDI-DI 10195327517977 Lot 25LBB534 DYNJ905293I UDI-DI 10198459247972 Lot 25KBM585 DYNJT8308 UDI-DI 10198459697135 Lot 26CBD040 CDS860087Q UDI-DI 10198459543005 Lots 25JBV094 25LBP061 DYNJ910084C UDI-DI 10198459597466 Lot 25LBE810 CDS982371I UDI-DI 10198459044106 Lots 25KBH343 26CBN241 CDS920099S UDI-DI 10195327140656 Lot 25KBO172 DYNJT3887 UDI-DI 10198459366871 Lot 25JBX564 DYNJT6876 UDI-DI 10198459583148 Lot 25KBM646 CDS984228K UDI-DI 10198459044113 Lot 26ABF608 DYNJ911843 UDI-DI 10198459555206 Lot 25LBC203 DYKMBNDL165C UDI-DI 10198459634284 Lot 25LBR024 CDS985442J UDI-DI 10198459476686 Lot 25JBT926 DYNJ84725B UDI-DI 10198459366949 Lot 25JBA329 DYNJ910594B UDI-DI 10198459563768 Lot 25KBJ104 DYNJ53711B UDI-DI 10198459023538 Lots 25KBF929 25LBB875 DYNJ83622C UDI-DI 10198459607172 Lots 25LBR740 26CBJ460 DYNJ909322B UDI-DI 10198459443848 Lot 25LBD961 DYNJ902583O UDI-DI 10198459441806 Lot 25LBC041
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2414-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2415-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2416-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2417-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2418-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2419-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2420-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2421-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2422-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2423-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2424-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2425-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2426-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2427-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2428-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2429-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2430-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2431-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2432-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2433-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2434-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2435-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2436-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2437-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2438-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2439-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2440-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2441-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2442-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2443-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2444-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2445-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2446-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2447-2026 | 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.