Cultura™ 00884450491102Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
All models of Cultura (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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
- Sep 16, 2020Class IITerminated
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Z-0454-2021 · Root cause: Device Design · Recall details · FDA record ↗
Other APPLICATOR, ABSORBENT TIPPED, STERILE devices
- Puritan HydraFlock 25-3317-HPuritan Medical Products · 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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