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Medical device recalls: July 2015

The FDA posted 440 medical device recall records in July 2015, from 125 recall events by 93 companies. 3 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. Biomet, Inc. · 5 events, 6 records
  2. GE Healthcare · 3 events, 18 records
  3. Philips Medical Systems (Cleveland) Inc · 3 events, 16 records
  4. Maquet Cardiovascular Us Sales, Llc · 3 events, 3 records
  5. Siemens Medical Solutions USA, Inc. · 3 events, 3 records
  6. Stryker Instruments Div. of Stryker Corporation · 3 events, 3 records
  7. Synthes (USA) Products LLC · 3 events, 3 records
  8. Covidien LLC · 2 events, 76 records

FDA root cause

  1. Nonconforming Material/Component · 152
  2. Device Design · 73
  3. Other · 46
  4. Reprocessing Controls · 32
  5. Process control · 26
  6. Software design · 23
  7. No Marketing Application · 10
  8. Error in labeling · 10

Class I recalls (3)

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

Class II recalls (428)

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

Class III recalls (9)

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.