Medline Industries, Inc. DYNJ45373GRecalls & reported problems
Medline Industries, Inc. · PED OPEN HEART PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 27, 2026Class IIOpen, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Z-2441-2026 · Root cause: Process control · Recall details · FDA record ↗
- Dec 12, 2025Class IIOpen, Classified
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Z-1193-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
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- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ44866PMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNDL1350AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ69692Medline Industries, Inc. · General surgery tray4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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