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Medical device recalls: January 2015

The FDA posted 133 medical device recall records in January 2015, from 96 recall events by 69 companies. 6 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. Siemens Medical Solutions USA, Inc · 7 events, 7 records
  2. Baxter Healthcare Corp. · 4 events, 4 records
  3. GE Healthcare · 4 events, 4 records
  4. DePuy Orthopaedics, Inc. · 3 events, 5 records
  5. Siemens Medical Solutions USA, Inc. · 3 events, 5 records
  6. Arrow International Inc · 3 events, 3 records
  7. Biomet Spine, LLC · 3 events, 3 records
  8. Synthes, Inc. · 3 events, 3 records

FDA root cause

  1. Device Design · 22
  2. Under Investigation by firm · 14
  3. Component change control · 13
  4. Software design · 12
  5. Component design/selection · 10
  6. Nonconforming Material/Component · 8
  7. Process control · 6
  8. Material/Component Contamination · 5

Class I recalls (6)

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

Class II recalls (122)

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.