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Medical device recalls: August 2023

The FDA posted 212 medical device recall records in August 2023, from 66 recall events by 48 companies. 35 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. Olympus Corporation of the Americas · 7 events, 25 records
  2. Datascope Corp. · 5 events, 10 records, 8 Class I
  3. Siemens Healthcare Diagnostics, Inc. · 3 events, 9 records
  4. Randox Laboratories Ltd. · 3 events, 3 records
  5. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 51 records
  6. Waldemar Link GmbH & Co. KG (Mfg Site) · 2 events, 13 records
  7. Philips North America · 2 events, 6 records
  8. Philips Medical Systems Nederland B.V. · 2 events, 3 records

FDA root cause

  1. Nonconforming Material/Component · 56
  2. Under Investigation by firm · 55
  3. Process control · 44
  4. Labeling Change Control · 21
  5. Device Design · 19
  6. Software design · 3
  7. Process design · 3
  8. Process change control · 2

Class I recalls (35)

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

Class II recalls (177)

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.