IsoLocRecalls & reported problems across all models
Radiadyne, L.L.C. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one IsoLoc model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of IsoLoc by Radiadyne, L.L.C. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier, 2 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
IsoLoc 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.
- Feb 4, 2025Class IIOpen, Classified
Product is mislabeled with the incorrect fill volume.
Z-1391-2025 · Root cause: Process control · Recall details · FDA record ↗
- May 21, 2024Class IIOpen, Classified
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Z-2267-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
IsoLoc models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IsoLoc ISO-100Prostate Immobilizer Rectal Balloon1 recall0 reports
- IsoLoc ISO-60Prostate Immobilizer Rectal Balloon1 recall0 reports
Other Radiadyne, L.L.C. products
All Radiadyne, L.L.C. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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