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Medical device recalls: October 2019

The FDA posted 232 medical device recall records in October 2019, from 19 recall events by 18 companies. 196 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. Baxter Healthcare Corporation · 2 events, 2 records
  2. Medtronic Vascular · 1 event, 191 records, 191 Class I
  3. Stryker Neurovascular · 1 event, 8 records
  4. Inter-Med Llc · 1 event, 7 records
  5. Candela Corporation · 1 event, 4 records
  6. Ethicon Endo-Surgery Inc · 1 event, 4 records, 4 Class I
  7. Xodus Medical Inc · 1 event, 3 records
  8. Ethicon, Inc. · 1 event, 2 records

FDA root cause

  1. Component design/selection · 192
  2. Process control · 8
  3. Employee error · 8
  4. Under Investigation by firm · 5
  5. Nonconforming Material/Component · 5
  6. Other · 4
  7. Packaging · 3
  8. Software design · 2

Class I recalls (196)

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

Class II recalls (32)

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

Class III recalls (4)

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.