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Medical device recalls: March 2015

The FDA posted 129 medical device recall records in March 2015, from 95 recall events by 69 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. GE Healthcare · 5 events, 5 records
  2. Siemens Medical Solutions USA, Inc · 5 events, 5 records
  3. Synthes, Inc. · 4 events, 4 records
  4. Baxter Healthcare Corp. · 3 events, 3 records
  5. Elekta, Inc. · 3 events, 3 records
  6. Philips Medical Systems, Inc. · 3 events, 3 records
  7. Siemens Healthcare Diagnostics Inc · 2 events, 7 records
  8. CooperSurgical, Inc. · 2 events, 5 records

FDA root cause

  1. Nonconforming Material/Component · 19
  2. Error in labeling · 17
  3. Device Design · 17
  4. Under Investigation by firm · 16
  5. Process control · 13
  6. Software design · 11
  7. Employee error · 5
  8. Radiation Control for Health and Safety Act · 4

Class I recalls (3)

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

Class II recalls (121)

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.