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Medical device recalls: April 2015

The FDA posted 207 medical device recall records in April 2015, from 98 recall events by 85 companies. 11 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. Beckman Coulter, Inc. · 3 events, 9 records
  2. GE Healthcare · 3 events, 5 records
  3. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  4. Biomet, Inc. · 2 events, 3 records
  5. Bard Access Systems · 2 events, 2 records
  6. Bard Peripheral Vascular Inc · 2 events, 2 records
  7. CooperSurgical, Inc. · 2 events, 2 records
  8. Pega Medical Inc. · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 57
  2. Under Investigation by firm · 19
  3. Packaging process control · 16
  4. Software design · 13
  5. Process design · 13
  6. Labeling False and Misleading · 12
  7. Employee error · 9
  8. Process control · 8

Class I recalls (11)

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

Class II recalls (193)

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

Class III recalls (3)

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.