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Medical device recalls: March 2016

The FDA posted 180 medical device recall records in March 2016, from 52 recall events by 45 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. Siemens Medical Solutions USA, Inc · 4 events, 5 records
  2. Biomet, Inc. · 3 events, 3 records
  3. Covidien LLC · 2 events, 36 records
  4. Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work · 2 events, 2 records
  5. Zimmer Manufacturing B.V. · 1 event, 72 records
  6. Arrow International, Inc., Division of Teleflex Medical Inc. · 1 event, 9 records, 9 Class I
  7. Ortho-Clinical Diagnostics · 1 event, 5 records
  8. Stryker Instruments Div. of Stryker Corporation · 1 event, 4 records

FDA root cause

  1. Packaging · 72
  2. Nonconforming Material/Component · 43
  3. Process control · 16
  4. Under Investigation by firm · 8
  5. Software design · 6
  6. Package design/selection · 6
  7. Error in labeling · 5
  8. Device Design · 4

Class I recalls (11)

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

Class II recalls (168)

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.