Z-2428-2026Class II
Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315... 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-2428-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
- Product code
- OJG Neurological Tray
- 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
- DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
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.