Bella Blankets 311Recalls & reported problems
Beekley Corporation · Protective Coverlets for Mammography - 29.2cm x 33.0cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815137020247), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K073262); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Product Quality Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem
THE MAMMOGRAM FOR TWO PATIENTS HAD TO BE REPEATED DUE TO IMAGE ARTIFACT. UPON FURTHER TESTING, IT WAS DETERMINED THE BELLA BLANKETS DID NOT CAUSE THE IMAGE ARTIFACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20263255 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K073262. One submission often covers many models, so check the product and lot details in each record.
- Z-2080-2012 · Jul 2, 2012 · TerminatedBella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between t
Other System, X-Ray, Mammographic devices
- Affirm Lateral Arm Upright Biopsy Accessory ASY-03723Hologic, Inc. · System, x-ray, mammographic1 recall3 reports
- Affirm Breast Biopsy Guidance System STLC-00004Hologic, Inc. · System, x-ray, mammographic24 reports
- Affirm Prone Biopsy System PBX-SYS-AFFIRM-3DHologic, Inc. · System, x-ray, mammographic23 reports
- FDR-2000BPY POSITIONER KIT BPY-L HA USA EFujifilm Corporation · System, X-Ray, Mammographic2 reports
- Multicare Platinum 8-004-0017Hologic, Inc. · System, x-ray, mammographic2 reports
- Affirm Prone Biopsy System PBX-SYS-AFFIRM-2DHologic, Inc. · System, x-ray, mammographic1 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 · each report above links to its original FDA record
- 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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