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Medical device recalls: November 2019

The FDA posted 26 medical device recall records in November 2019, from 9 recall events by 9 companies. 9 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. Boston Scientific Corporation · 1 event, 13 records
  2. Philips Medical Systems (Cleveland) Inc · 1 event, 5 records, 5 Class I
  3. Medtronic Inc. · 1 event, 2 records, 2 Class I
  4. Abbott Gmbh & Co. KG · 1 event, 1 record
  5. Implant Direct Sybron Manufacturing, LLC · 1 event, 1 record
  6. Medtech Sas · 1 event, 1 record, 1 Class I
  7. Philips North America, LLC · 1 event, 1 record
  8. Spineart SA · 1 event, 1 record

FDA root cause

  1. Incorrect or no expiration date · 13
  2. Nonconforming Material/Component · 5
  3. Software design · 2
  4. Software in the Use Environment · 1
  5. Process control · 1
  6. Packaging · 1
  7. Material/Component Contamination · 1
  8. Employee error · 1

Class I recalls (9)

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

Class II recalls (16)

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.