Skip to content

Medical device recalls: May 2014

The FDA posted 146 medical device recall records in May 2014, from 87 recall events by 69 companies. 9 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 · 6 events, 6 records
  2. Hospira Inc. · 3 events, 8 records, 3 Class I
  3. Teleflex Medical · 2 events, 9 records
  4. Siemens Healthcare Diagnostics, Inc · 2 events, 8 records
  5. GE Healthcare · 2 events, 6 records
  6. Fresenius Medical Care Holdings, Inc. · 2 events, 3 records, 1 Class I
  7. Alere San Diego, Inc. · 2 events, 2 records, 1 Class I
  8. Baxter Corporation Englewood · 2 events, 2 records, 1 Class I

FDA root cause

  1. Nonconforming Material/Component · 38
  2. Device Design · 19
  3. Software design · 18
  4. Under Investigation by firm · 9
  5. Process design · 9
  6. Process control · 9
  7. Employee error · 8
  8. Labeling mix-ups · 5

Class I recalls (9)

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

Class II recalls (136)

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

Class III recalls (1)

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.