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Medical device recalls: October 2017

The FDA posted 8 medical device recall records in October 2017, from 6 recall events by 6 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. Permobil, Ab · 1 event, 2 records
  2. St Jude Medical Inc. · 1 event, 2 records, 2 Class I
  3. OriGen Biomedical, Inc. · 1 event, 1 record, 1 Class I
  4. Sysmex America, Inc. · 1 event, 1 record
  5. Teleflex Medical · 1 event, 1 record
  6. W L Gore & Associates, Inc. · 1 event, 1 record

FDA root cause

  1. Device Design · 4
  2. Unknown/Undetermined by firm · 1
  3. Under Investigation by firm · 1
  4. Process control · 1
  5. Nonconforming Material/Component · 1

Class I recalls (3)

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

Class II recalls (5)

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

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.