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Medical device recalls: February 2022

The FDA posted 22 medical device recall records in February 2022, from 10 recall events by 10 companies. 12 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. Teleflex Medical Inc · 1 event, 7 records, 7 Class I
  2. Microbiologics Inc · 1 event, 5 records
  3. Collagen Matrix, Inc. · 1 event, 2 records
  4. Respironics California, LLC · 1 event, 2 records, 2 Class I
  5. Abiomed, Inc. · 1 event, 1 record, 1 Class I
  6. Becton Dickinson & Co. · 1 event, 1 record
  7. Covidien Llc · 1 event, 1 record
  8. E25Bio, Inc. · 1 event, 1 record, 1 Class I

FDA root cause

  1. Process change control · 7
  2. Process design · 5
  3. Under Investigation by firm · 2
  4. Process control · 2
  5. Nonconforming Material/Component · 2
  6. Software design (manufacturing process) · 1
  7. Software change control · 1
  8. No Marketing Application · 1

Class I recalls (12)

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

Class II recalls (10)

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.