SURGICOUNTRecalls & reported problems across all models
Stryker Corporation · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SURGICOUNT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 20 models of SURGICOUNT by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2022 and Jul 29, 2026 — classified as 2 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (26 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 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. 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
SURGICOUNT recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 10, 2023Open, Classified
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Z-2463-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 15, 2022Terminated
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
Z-1452-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported SURGICOUNT problems
Device problems
- Material Frayed26
- Detachment of Device or Device Component7
- Delivered as Unsterile Product5
- False Positive Result4
- High Readings3
- Low Readings2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information2
- Laceration(s)1
SURGICOUNT models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURGICOUNT 0694002090Counter, sponge, surgical2 recalls0 reports
- SURGICOUNT 0632244160GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE12 reports
- SurgiCount 0894000005Counter, sponge, surgical6 reports
- SURGICOUNT 0631018180GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE5 reports
- SURGICOUNT 0632284120GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE4 reports
- SURGICOUNT 0621018180GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE4 reports
- SURGICOUNT 0622284120GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE3 reports
- SurgiCount 0694-001-010Counter, sponge, surgical2 reports
- SURGICOUNT 0631218180GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- SURGICOUNT 0622244160GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- SURGICOUNT 0622284160GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- SURGICOUNT 0694002002Counter, sponge, surgical1 report
- SurgiCount 0894000003Counter, sponge, surgical1 report
- SURGICOUNT 0632022120Gauze/sponge, internal, x-ray detectable1 report
- SURGICOUNT 0632284160GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
- SURGICOUNT 0632344160GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
- SURGICOUNT 0631004180GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
- SURGICOUNT 0694002010Counter, sponge, surgical1 report
- SURGICOUNT 0621108360GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
- SURGICOUNT 0621118180GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
Recent SURGICOUNT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Material Frayed
I was reported that during a robotic abdominal procedure, a 4 x 4 Ray-Tec sponge visibly frayed and the radiopaque marker began to separate from the sponge. Upon removal, multiple fragments of frayed sponge material were found to have detached and remained within the patient¿s abdomen. The procedure was converted to an open abdominal approach due to unrelated intraoperative complications, which allowed the surgical team to irrigate and inspect the abdominal cavity and remove all visible fragments before closure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070606 ↗MalfunctionFeb 6, 2026False Negative Result
THE CUSTOMER REPORTED THAT DURING A CASE, SPONGES WERE SCANNED IN AND THEN OUT, AN ERROR OCCURRED AND THE CASE REPORTED NONE OF THE SPONGES WERE SCANNED OUT. AN X-RAY WAS TAKEN TO CONFIRM NO SPONGES WERE RETAINED. NO ADVERSE CONSEQUENCES OR ADDITIONAL MEDICAL INTERVENTION WAS TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279483 ↗MalfunctionOct 28, 2025Material Frayed; Material Frayed
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399945 ↗MalfunctionOct 28, 2025Material Frayed; Material Frayed
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: MATERIAL FRAYED. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399934 ↗MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399922 ↗MalfunctionOct 28, 2025Low Readings; Low Readings
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399870 ↗MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DELIVERED AS UNSTERILE PRODUCT, 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT, 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399856 ↗MalfunctionOct 28, 2025Material Frayed; Material Frayed
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD INSUFFICIENT INFORMATION.
Patient problems: Insufficient Information; Laceration(s)
MAUDE report 23399825 ↗MalfunctionOct 28, 2025High Readings; High Readings
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: HIGH READINGS. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399794 ↗MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399786 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368316 ↗MalfunctionJul 29, 2025Low Readings; Low Readings
THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: LOW READINGS. - 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648155 ↗MalfunctionJul 29, 2025Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648147 ↗MalfunctionJul 29, 2025High Readings; High Readings
THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: HIGH READINGS. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648141 ↗MalfunctionJul 29, 2025Material Frayed; Material Frayed
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648132 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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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