Site-RiteRecalls & reported problems across all models
Bard Access Systems, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,020
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 20 models of Site-Rite by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,020 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2016 and Apr 13, 2026 — classified as 5 injuries, 1,015 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (262 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 Site-Rite problems
Device problems
- Poor Quality Image262
- Battery Problem197
- Loss of Power185
- Defective Component150
- No Apparent Adverse Event89
- Unexpected Shutdown74
- Application Program Freezes or Fails to Launch52
- No Display/Image40
Patient problems
- No Consequences Or Impact To Patient402
- No Clinical Signs, Symptoms or Conditions393
- No Known Impact Or Consequence To Patient308
- No Information25
- No Patient Involvement11
- Discomfort4
- Needle Stick/Puncture2
- No Code Available2
Site-Rite models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Site-Rite 9770501System, imaging, pulsed echo, ultrasonic546 reports
- Site-Rite 9770500System, image processing, radiological140 reports
- Site-Rite 9770086RTransducer, ultrasonic, diagnostic113 reports
- Site-Rite 9770086Transducer, ultrasonic, diagnostic57 reports
- Site-Rite 900013B01Transducer, ultrasonic, diagnostic55 reports
- Site-Rite 9770090RTransducer, ultrasonic, diagnostic29 reports
- Site-Rite 9770501RSystem, imaging, pulsed echo, ultrasonic21 reports
- Site-Rite 9770090Transducer, ultrasonic, diagnostic12 reports
- Site-Rite 9001C0197Transducer, ultrasonic, diagnostic9 reports
- Site-Rite 9770500RSystem, imaging, pulsed echo, ultrasonic9 reports
- Site-Rite 9770001Transducer, ultrasonic, diagnostic8 reports
- Site-Rite 9001C0212Transducer, ultrasonic, diagnostic6 reports
- Site-Rite 9770177RSystem, imaging, pulsed doppler, ultrasonic4 reports
- Site-Rite 9770169Transducer, ultrasonic, diagnostic3 reports
- Site-Rite 9770168Transducer, ultrasonic, diagnostic2 reports
- Site-Rite 9760034Transducer, ultrasonic, diagnostic2 reports
- Site-Rite 9000096Transducer, ultrasonic, diagnostic1 report
- Site-Rite 9770176RSystem, imaging, pulsed echo, ultrasonic1 report
- Site-Rite 9770169RTransducer, ultrasonic, diagnostic1 report
- Site-Rite 9770001RTransducer, ultrasonic, diagnostic1 report
Recent Site-Rite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Poor Quality Image
IT WAS REPORTED UNIT IS GIVING DARK, SNOWY IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865566 ↗MalfunctionApr 6, 2026Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE IMAGE APPEARS YELLOWISH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793635 ↗MalfunctionMar 25, 2026Product Quality Problem
IT WAS REPORTED THAT DURING PICC CATHETER INSERTION, A HOLE WAS DISCOVERED IN THE STERILE PROTECTIVE COVER WHILE APPLYING THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688224 ↗MalfunctionFeb 19, 2026Product Quality Problem
IT WAS REPORTED THE UNIT IS GIVING EC101. A REBOOT CLEARS THE ERROR BUT THEY ARE HAVING TO REBOOT IT EVERY TIME THEY USE THE MACHINE. 18 FEB 2026 EVALUATION FOUND SNOW AT THE BOTTOM OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392770 ↗MalfunctionFeb 11, 2026Poor Quality Image
IT WAS REPORTED THE SCREEN ON THE SCANNER COMPLETELY DIMS OUT DURING USE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316521 ↗MalfunctionJan 29, 2026Product Quality Problem
IT WAS REPORTED THE PROBE PROTECTIVE SLEEVE VISIBLE TO THE NAKED EYE HAS A SMALL DAMAGE, FOR THE REPLACEMENT OF THE NEW KIT, DAMAGED KIT ON-SITE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209131 ↗MalfunctionJan 23, 2026Product Quality Problem
FOUND DURING EVALUATION: THERE ARE CRACKS IN THE TRANSDUCER HOUSINGS AT THE END AND ON THE EDGES OF THE TRANSDUCER WINDOW. THE PROBE IMAGE IS NOT CLEAR AT THE TOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162119 ↗MalfunctionDec 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE QUALITY IS DEGRADED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866114 ↗MalfunctionDec 9, 2025Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image
IT WAS REPORTED THAT THE SCREEN IS PIXILATED OR FROZE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23763962 ↗MalfunctionDec 2, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED GT PROBE GIVING GRAINY IMAGING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696397 ↗MalfunctionNov 18, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING ISSUES WITH THE PROBE/IMAGE QUALITY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584794 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE CORD ON THE PROBE IS PULLING AWAY AT THE STRAIN RELIEF/EXPOSING WIRING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584396 ↗MalfunctionNov 4, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SCREEN IS TOO DARK, SETTINGS WILL NOT CHANGE HOW DARK IT IS WHEN USING THE PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23471900 ↗MalfunctionOct 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY A TM THAT THE IMAGE IS GRAINY AND NOT VERY GOOD. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423892 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
FOUND DURING EVALUATION: THE IMAGE HAS A DROP GOING DOWN THE CENTER, THE PROBLEM IS TRACED TO A "SLIT MARK" ON THE FACE OF THE PROBE. THIS UNIT WILL HAVE TO BE RE-MANED TO ALLOW FOR A DETACHABLE PROBE, SINCE THE GT PROBE IS NO LONGER SUPPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352224 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
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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