Z-2415-2026Class II
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 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-2415-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
- Product code
- OFT Spinal Epidural Anesthesia 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
- DYNJRA2742 UDI-DI 10198459627330 Lot 26AMA185 DYNJRA2716 UDI-DI 10198459567988 Lot 25KBA971
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.