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MEDLINE SBCH22GRecalls & reported problems

Medline Industries, Inc. · SFTY BLD COLL HLDR 22GX1.25"" · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197344039715), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 21, 2026Leak/Splash

    (B)(6) HOSPITAL HAS NOTICED AN ISSUE WITH THE MOST RECENT LOT OF PRODUCTS SBCH21G AND SBCH22G. THE RUBBER OF THE DISTAL NEEDLE IS NOT MOVING BACK INTO THE CORRECT PLACE AFTER THE END USER FILLS AVACUTAINER TUBE WITH BLOOD. THIS IS CAUSING THE NEEDLE TO REMAIN EXPOSED AND LEAK BLOOD ONTO THE NEXT VACUTAINER THAT THE END USER IS TRYING TO FILL. THIS CUSTOMER HAS NOT EXPERIENCED THIS ISSUE WITH THE PRODUCT SINCE IT CONVERTED IN AUGUST, WHICH MAKES IT SEEM LIKE IT'S A LOT OF ISSUE. THERE HAVE BEEN 10 SEPARATE INCIDENTS AMONG 10 DIFFERENT END USERS, INCLUDING THE PHLEBOTOMY SUPERVISOR. THE CUSTOMER WOULD LIKE TO REPLACE THE INVENTORY THEY HAVE WITH INVENTORY FROM A NEW LOT NUMBER.

    Patient problems: Insufficient Information

    MAUDE report 24127462 ↗

Other Tubes, vials, systems, serum separators, blood collection devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.