FDA Class I device recall events ticked up in FY 2022

Regulatory NewsRegulatory News | 06 December 2022 |  By 

While the total number of the most serious medical device recalls in the US has declined in recent years, the number of recall events has steadily increased, according to data from the Food and Drug Administration (FDA).
Focus analyzed FDA data from FY 2018-2022 and found that during the most recent fiscal year, the agency recorded 72 medical device Class I recall events comprised of 149 product recalls. The number of recall events reflects how many recalls occurred, while the total number of recalled products may be higher as multiple individual products may be recalled within a single recall event.
By comparison, in FY 2021 the agency recorded 64 Class I recall events that included 169 products. The data show that the agency has seen a steady increase in the number of recall events in recent years, though the total number of recalled products has declined since spiking in 2019.


Reviewing the data from FY 2022, Focus found that Medtronic and its subsidiary Covidien topped the list of companies that issued a Class I recall in terms of number of product recalls.
Covidien issued 26 recalls for its Palindrome chronic dialysis catheters due to concerns about leakage and Puritan Bennett 980 ventilators due to manufacturing errors. Covidien’s parent company Medtronic issued 14 recalls for products including its Harmony Delivery Catheter System, HeartWare Ventricular Assist Device (HVAD) and Cobalt Implantable Cardioverter Defibrillators.
Respironics, a US-based Philips subsidiary issued 13 Class I recalls for its bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to concerns about manufacturing problems and failure to label certain contraindications on their products.
Other major manufacturers who have issued significant number of Class I recalls in the previous fiscal year include Abbott for their Alinity SARS-CoV-2 diagnostic system, Baxter for issues with their infusion pumps and ventilator adaptors, and Smiths Medical for issues with their Medfusion syringe pumps.

When looking at less serious recalls, FDA recorded a decline in Class II recall events – the most numerous type of recall – from FY 2018-2022, with 782 recall events in FY 2022, down from 1,100 in FY 2018. Class III recalls – the least serious and least numerous type – remained relatively flat over the same period, with 45 recall events in FY 2018 and 44 in FY 2022.


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