Skip to content

Medical device recalls: January 2013

The FDA posted 132 medical device recall records in January 2013, from 69 recall events by 59 companies. 4 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. Becton Dickinson & Co. · 3 events, 3 records
  2. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  3. DePuy Spine, Inc. · 2 events, 10 records
  4. Horiba Instruments, Inc dba Horiba Medical · 2 events, 3 records
  5. Biomet, Inc. · 2 events, 2 records
  6. Mindray DS USA, Inc. d.b.a. Mindray North America · 2 events, 2 records
  7. Philips Medical Systems (Cleveland) Inc · 2 events, 2 records
  8. Stryker Howmedica Osteonics Corp. · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 35
  2. Equipment maintenance · 22
  3. Process control · 14
  4. Software design · 12
  5. Device Design · 10
  6. Component change control · 10
  7. Employee error · 4
  8. Component design/selection · 4

Class I recalls (4)

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

Class II recalls (104)

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

Class III recalls (24)

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.