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Medical device recalls: April 2017

The FDA posted 76 medical device recall records in April 2017, from 50 recall events by 45 companies. 4 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. Beckman Coulter Inc. · 3 events, 3 records
  2. Zimmer Biomet, Inc. · 3 events, 3 records
  3. Merge Healthcare, Inc. · 2 events, 2 records
  4. Windstone Medical Packaging, Inc. · 1 event, 18 records
  5. Philips Medical Systems (Cleveland) Inc · 1 event, 4 records
  6. Aesculap Implant Systems LLC · 1 event, 3 records
  7. Oscor, Inc. · 1 event, 2 records, 2 Class I
  8. Siemens Healthcare Diagnostics, Inc · 1 event, 2 records

FDA root cause

  1. Nonconforming Material/Component · 27
  2. Process control · 13
  3. Software design · 8
  4. Under Investigation by firm · 4
  5. Mixed-up of materials/components · 3
  6. Labeling mix-ups · 3
  7. Process design · 2
  8. Other · 2

Class I recalls (4)

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

Class II recalls (70)

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

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.