Z-2446-2026Class II
Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P 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-2446-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P
- Product code
- OHM Cesarean Section 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
- CDS985505G UDI-DI 10195327412555 Lot 26AMC363 DYNJ68260D UDI-DI 10195327506513 Lot 25KBE168 DYNJ905094B UDI-DI 10193489858174 Lot 25KMB136 CDS820091P UDI-DI 10195327403539 Lots 26BBO404 26CBN891
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.