Skip to content

Medical device recalls: February 2020

The FDA posted 157 medical device recall records in February 2020, from 48 recall events by 36 companies. 40 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. Theralase Inc. · 4 events, 4 records
  2. Implant Direct Sybron Manufacturing LLC · 3 events, 3 records
  3. Covidien Llc · 2 events, 29 records
  4. Deroyal Industries, Inc. Lafollette · 2 events, 11 records
  5. Teleflex Medical Inc · 2 events, 6 records, 4 Class I
  6. Ethicon, Inc. · 2 events, 4 records
  7. Abbott Point Of Care Inc. · 2 events, 3 records
  8. Siemens Healthcare Diagnostics, Inc. · 2 events, 3 records

FDA root cause

  1. Equipment maintenance · 28
  2. Packaging process control · 25
  3. Software design · 17
  4. Process change control · 17
  5. Process control · 12
  6. Device Design · 12
  7. Under Investigation by firm · 11
  8. Environmental control · 10

Class I recalls (40)

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

Class II recalls (111)

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

Class III recalls (6)

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.