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Medical device recalls: September 2018

The FDA posted 186 medical device recall records in September 2018, from 10 recall events by 9 companies. 24 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. Swissray Medical · 2 events, 2 records
  2. Zimmer Biomet, Inc. · 1 event, 129 records
  3. Philips Electronics North America Corporation · 1 event, 27 records
  4. Ventana Medical Systems Inc · 1 event, 21 records, 21 Class I
  5. Pro-Med Instruments Gmbh · 1 event, 3 records, 3 Class I
  6. Accuray Incorporated · 1 event, 1 record
  7. Agfa N.V. · 1 event, 1 record
  8. Leica Microsystems, Inc. · 1 event, 1 record

FDA root cause

  1. Under Investigation by firm · 150
  2. Device Design · 30
  3. Component change control · 3
  4. Nonconforming Material/Component · 2
  5. Component design/selection · 1

Class I recalls (24)

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

Class II recalls (162)

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.