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Medical device recalls: May 2021

The FDA posted 32 medical device recall records in May 2021, from 6 recall events by 6 companies. 9 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Biopsybell S.R.L. · 1 event, 19 records
  2. Medical Action Industries, Inc. 306 · 1 event, 6 records, 6 Class I
  3. GE Healthcare, LLC · 1 event, 3 records
  4. St. Jude Medical, Cardian Rhythm Management Division · 1 event, 2 records, 2 Class I
  5. Greiner Bio-One North America, Inc. · 1 event, 1 record
  6. Step-Har Medical LLC · 1 event, 1 record, 1 Class I

FDA root cause

  1. Vendor change control · 19
  2. Package design/selection · 6
  3. Process control · 3
  4. Device Design · 3
  5. Component design/selection · 1

Class I recalls (9)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (23)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.