Skip to content

Medical device recalls: April 2016

The FDA posted 176 medical device recall records in April 2016, from 43 recall events by 36 companies. 10 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. Siemens Medical Solutions USA, Inc · 4 events, 7 records
  2. Synthes (USA) Products LLC · 2 events, 3 records
  3. Fresenius Medical Care Renal Therapies Group, LLC · 2 events, 2 records
  4. Stryker Instruments Div. of Stryker Corporation · 2 events, 2 records
  5. Stryker Medical Division of Stryker Corporation · 2 events, 2 records
  6. Customed, Inc · 1 event, 100 records
  7. Smith & Nephew, Inc. · 1 event, 15 records
  8. Dexcom Inc · 1 event, 6 records, 6 Class I

FDA root cause

  1. Packaging · 100
  2. Process control · 24
  3. Device Design · 13
  4. Software design · 8
  5. Nonconforming Material/Component · 8
  6. Under Investigation by firm · 5
  7. Labeling design · 3
  8. Employee error · 3

Class I recalls (10)

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

Class II recalls (166)

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.