GIBSON HEALTHCARERecalls & reported problems across all models
Benco Dental Supply CO. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one GIBSON HEALTHCARE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 7
We found 8 models of GIBSON HEALTHCARE by Benco Dental Supply CO. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 12, 2025 and Nov 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
7 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
GIBSON HEALTHCARE 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.
- Aug 3, 2022Open, Classified
The packaging may not be sealed, which could compromise sterility.
Z-1777-2022 · Root cause: Packaging change control · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0912-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0911-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0910-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0909-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0908-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 5, 2019Terminated
The products may have been packaged with an incorrect Instructions for Use.
Z-0907-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported GIBSON HEALTHCARE problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
GIBSON HEALTHCARE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GIBSON HEALTHCARE 5303-235Barrier, Animal Source, Intraoral2 recalls0 reports
- GIBSON HEALTHCARE 5251-194Dressing, Wound, Collagen1 recall0 reports
- GIBSON HEALTHCARE 5303-226Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-306Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-324Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-342Barrier, Animal Source, Intraoral1 recall0 reports
- Gibson Healthcare 1975-160Suture, Absorbable, Natural1 report
- Gibson Healthcare 4071-952Suture, Nonabsorbable, Synthetic, Polyamide1 report
Recent GIBSON HEALTHCARE adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED ON 3 OCTOBER 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO REMOVE IT FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589159 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. THE NEEDLE AND ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE SITE AND NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006219 ↗
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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