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Medical device recalls: June 2012

The FDA posted 227 medical device recall records in June 2012, from 63 recall events by 54 companies. 17 are Class I, the most serious category. 80 have not been classified yet.

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. Philips Healthcare Inc. · 5 events, 5 records
  2. Terumo Cardiovascular Systems Corporation · 2 events, 31 records
  3. Arrow International Inc · 2 events, 2 records, 1 Class I
  4. Invacare Corporation · 2 events, 2 records
  5. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records
  6. Spacelabs Healthcare, Llc · 2 events, 2 records
  7. Smith & Nephew Inc · 1 event, 65 records
  8. DePuy Orthopaedics, Inc. · 1 event, 19 records

FDA root cause

  1. Packaging · 66
  2. Nonconforming Material/Component · 35
  3. Device Design · 29
  4. Material/Component Contamination · 22
  5. Component design/selection · 20
  6. Process control · 8
  7. Software design · 7
  8. Package design/selection · 5

Class I recalls (17)

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

Class II recalls (125)

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.

Not yet classified (80)

The FDA has posted these records but has not published a class for them yet.

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.