Puritan HydraFlock 25-3317-HRecalls & reported problems
Puritan Medical Products · Sterile Flocked Collection Devices · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 21, 2024Class IIOpen, Classified
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Z-1391-2024 · Root cause: Process control · Recall details · FDA record ↗
Other Applicator, Absorbent Tipped, Sterile devices
- Cultura™ 00884450491102Merit Medical Systems, Inc. · APPLICATOR, ABSORBENT TIPPED, STERILE1 recall0 reports
- Sterile Polyester Spun Swab 25 Pack 60566Steripack (usa) Limited LLC · Applicator, Absorbent Tipped, Sterile1 recall0 reports
- Cultura™ 00884450495834Merit Medical Systems, Inc. · APPLICATOR, ABSORBENT TIPPED, STERILE2 reports
- Specimen Collection Swab SW0102Typenex Medical LLC · Applicator, Absorbent Tipped, Sterile2 reports
- Medline MDS202105Medline Industries, Inc. · Applicator, absorbent tipped, sterile1 report
- DeRoyal 31-249Deroyal Industries, Inc. · APPLICATOR, ABSORBENT TIPPED, STERILE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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