SharpSafetyRecalls & reported problems across all models
Cardinal Health, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of SharpSafety by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2019 and May 8, 2026 — classified as 1 injury, 71 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (58 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SharpSafety problems
Device problems
- Device Contaminated During Manufacture or Shipping58
- Break5
- Crack4
- Material Separation2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Open or Close1
- Fail-Safe Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Consequences Or Impact To Patient2
- Needle Stick/Puncture1
- No Patient Involvement1
SharpSafety models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SharpSafety 8556HContainer, Sharps65 reports
- SharpSafety 31144010Container, sharps2 reports
- SharpSafety 8537SAContainer, sharps1 report
- SharpSafety 8964Needle, hypodermic, single lumen1 report
- SharpSafety 8527RContainer, Sharps1 report
- SharpSafety 8979CNeedle, hypodermic, single lumen1 report
- SharpSafety 85221Container, sharps1 report
Recent SharpSafety adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 17 REPRESENTATIVE SAMPLES FOR ANALYSIS . NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128115 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111007 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111004 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111001 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110999 ↗MalfunctionMay 6, 2026Material Separation; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT A BY-PASS PROCEDURE IN 2026 AND SUTURE WAS USED. DURING SEWING ON BY-PASS OP, THE NEEDLE HAD COME OFF THE THREAD WITH SEVERAL SEAMS. IN ADDITION, THE NEEDLE OF THE LAST AFFECTED SUTURE WAS BENT AT THE SWAGED AREA. NO PATIENT HARM OCCURRED. USING NEW SUTURES FROM THESE LOTS, THE SURGICAL PROCEDURE WAS CONTINUED AS PLANNED AND COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095804 ↗MalfunctionMay 6, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A BY-PASS PROCEDURE IN 2026 AND SUTURE WAS USED. DURING SEWING ON BY-PASS OP, THE NEEDLE HAD COME OFF THE THREAD WITH SEVERAL SEAMS. IN ADDITION, THE NEEDLE OF THE LAST AFFECTED SUTURE WAS BENT AT THE SWAGED AREA. NO PATIENT HARM OCCURRED. USING NEW SUTURES FROM THESE LOTS, THE SURGICAL PROCEDURE WAS CONTINUED AS PLANNED AND COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095801 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746620 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746526 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746506 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746486 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746411 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746408 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746406 ↗MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746387 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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