Skip to content

Medical device recalls: March 2024

The FDA posted 229 medical device recall records in March 2024, from 82 recall events by 64 companies. 18 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 · 5 events, 8 records
  2. Boston Scientific Corporation · 4 events, 4 records, 2 Class I
  3. Ortho-Clinical Diagnostics, Inc. · 3 events, 13 records
  4. Olympus Corporation of the Americas · 3 events, 4 records
  5. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 30 records
  6. Waldemar Link GmbH & Co. KG (Mfg Site) · 2 events, 6 records
  7. Peter Lazic Gmbh · 2 events, 5 records
  8. Siemens Healthcare Diagnostics, Inc. · 2 events, 3 records

FDA root cause

  1. Process control · 73
  2. Under Investigation by firm · 53
  3. Nonconforming Material/Component · 28
  4. Device Design · 11
  5. Software Design Change · 10
  6. Software design · 9
  7. Packaging · 8
  8. Packaging change control · 6

Class I recalls (18)

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

Class II recalls (211)

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.