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Medical device recalls: May 2015

The FDA posted 138 medical device recall records in May 2015, from 82 recall events by 60 companies. 3 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. Philips Medical Systems (Cleveland) Inc · 5 events, 15 records
  2. GE Healthcare · 4 events, 4 records
  3. Stryker Instruments Div. of Stryker Corporation · 3 events, 14 records
  4. Siemens Medical Solutions USA, Inc · 3 events, 8 records
  5. Fujifilm Medical Systems U.S.A., Inc. · 3 events, 3 records
  6. Zimmer, Inc. · 3 events, 3 records
  7. Philips Ultrasound, Inc. · 2 events, 4 records
  8. Stryker Howmedica Osteonics Corp. · 2 events, 4 records

FDA root cause

  1. Software design · 22
  2. Under Investigation by firm · 16
  3. Package design/selection · 13
  4. Nonconforming Material/Component · 13
  5. Device Design · 13
  6. Process control · 12
  7. Employee error · 12
  8. Other · 7

Class I recalls (3)

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

Class II recalls (129)

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.