MEDLINE SBCH21GRecalls & reported problems
Medline Industries, Inc. · SFTY BLD COLL HLDR 21GX1.25"" · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10197344039708), received between Jan 21, 2026 and Sep 25, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).
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
Most reported problems
Device problems
- Fluid/Blood Leak11
- Retraction Problem3
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904632 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that "The rubber of the distal needle is not moving back into the correct place after the end user fills a vacutainer 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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842865 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that "The rubber of the distal needle is not moving back into the correct place after the end user fills a vacutainer 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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839853 ↗MalfunctionSep 18, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823374 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804729 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790644 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported that "The rubber of the distal needle is not moving back into the correct place after the end user fills a vacutainer 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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772561 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763607 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746025 ↗MalfunctionSep 11, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743535 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699661 ↗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 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 24127463 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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