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Medical device recalls: July 2021

The FDA posted 62 medical device recall records in July 2021, from 12 recall events by 8 companies. 15 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. GE Healthcare, LLC · 3 events, 16 records
  2. Boston Scientific Corporation · 2 events, 12 records, 6 Class I
  3. Philips Respironics, Inc. · 2 events, 6 records, 6 Class I
  4. Exactech, Inc. · 1 event, 22 records
  5. Magellan Diagnostics, Inc. · 1 event, 3 records, 3 Class I
  6. Implantcast GMBH · 1 event, 1 record
  7. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 1 record
  8. Vivorte, Inc. · 1 event, 1 record

FDA root cause

  1. Unknown/Undetermined by firm · 22
  2. Software design · 15
  3. Device Design · 13
  4. Nonconforming Material/Component · 9
  5. Software Manufacturing/Software Deployment · 1
  6. Radiation Control for Health and Safety Act · 1
  7. Labeling Change Control · 1

Class I recalls (15)

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

Class II recalls (47)

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.