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Medical device recalls: May 2016

The FDA posted 106 medical device recall records in May 2016, from 46 recall events by 39 companies. 18 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. Biomet, Inc. · 2 events, 15 records
  2. Covidien LLC · 2 events, 15 records
  3. Biomerieux Inc · 2 events, 10 records, 9 Class I
  4. Alcon Research, Ltd. · 2 events, 4 records
  5. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records
  6. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  7. Skytron, Div. The KMW Group, Inc · 2 events, 2 records
  8. Zimmer Manufacturing B.V. · 1 event, 12 records

FDA root cause

  1. Equipment maintenance · 14
  2. Packaging process control · 13
  3. Packaging change control · 12
  4. Device Design · 11
  5. Process control · 10
  6. Labeling Change Control · 9
  7. Software design · 7
  8. Other · 5

Class I recalls (18)

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

Class II recalls (87)

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

Class III recalls (1)

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.