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Medical device recalls: August 2015

The FDA posted 204 medical device recall records in August 2015, from 105 recall events by 83 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. Synthes (USA) Products LLC · 6 events, 6 records
  2. Trilliant Surgical Ltd. · 5 events, 5 records
  3. Stryker Howmedica Osteonics Corp. · 4 events, 8 records
  4. Siemens Medical Solutions USA, Inc · 2 events, 4 records
  5. Siemens Medical Solutions USA, Inc. · 2 events, 4 records
  6. GE Healthcare · 2 events, 3 records
  7. Omnilife Science Inc. · 2 events, 3 records
  8. Roche Diagnostics Operations, Inc. · 2 events, 3 records

FDA root cause

  1. Process control · 53
  2. Nonconforming Material/Component · 28
  3. Device Design · 18
  4. Unknown/Undetermined by firm · 13
  5. Packaging change control · 13
  6. Other · 12
  7. Under Investigation by firm · 11
  8. Software design · 10

Class I recalls (15)

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

Class II recalls (184)

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

Class III recalls (5)

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.