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Medical device recalls: May 2017

The FDA posted 270 medical device recall records in May 2017, from 47 recall events by 38 companies. 12 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, 3 records
  2. Medtest Holdings, Inc. · 3 events, 3 records
  3. Merge Healthcare, Inc. · 3 events, 3 records
  4. Orthosoft, Inc. dba Zimmer CAS · 3 events, 3 records
  5. BioMerieux SA · 2 events, 2 records
  6. Biomerieux Inc · 1 event, 187 records
  7. ConvaTec, Inc · 1 event, 18 records
  8. Breg Inc · 1 event, 8 records

FDA root cause

  1. Packaging · 187
  2. Process control · 22
  3. Device Design · 14
  4. Employee error · 9
  5. Under Investigation by firm · 8
  6. Other · 8
  7. Software design · 6
  8. Nonconforming Material/Component · 5

Class I recalls (12)

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

Class II recalls (252)

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

Class III recalls (6)

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.