FDA issues 60 medical device recalls in 2022

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Medical device recalls overview: 

• Who: Philips Respironics, Celltrion USA, LuSys Laboratories, Mesa Biotech, E25Bio and Medtronic initiated recalls for medical devices last year. 
• Why: The medical device recalls were collectively for COVID-19 test kits, ventilators and delivery catheters. 
• Where: Companies nationwide recalled the medical devices. 

The U.S. Food and Drug Administration (FDA) issued a number of medical device recalls last year, including for COVID-19 test kits, ventilators and delivery catheters. 

A medical device may be recalled in the event it is deemed defective or poses a danger to human health. 

Philip Respironics recalls ventilators, repair kits over concerns 

Philips Respironics initiated a recall for 215 of its Trilogy Evo ventilators and 51 of its ventilator repair kits last February over concerns they contained potentially carcinogenic polyester-based polyurethane sound abatement foam.

The Class 1 recall was on account of a Phillips supplier incorrectly using the polyester-based sound abatement foam in the muffler assembly for certain of the company’s Trilogy Evo ventilators and repair kits. 

In its recall notice, Philips says the issue was found during lab testing and the company had received no reports of injury or death in connection with the recall. 

Another recall involving Philips ventilators was conducted in March 2022 over concerns the breathing devices were manufactured with parts containing an expired adhesive that could cause them to stop working suddenly. 

Philips recalled a total of 1,511 of its V60 and V60 Plus ventilators on account of the issue, with the recall in effect throughout the country. 

In a Class 1 recall posted by the FDA, the agency says a capacitor support bracket in the ventilator could potentially damage the devices in the event the adhesive fails, causing them to stop providing ventilation. 

Celltrion USA recalls pair of COVID-19 test kits 

In March 2022, Celltrion USA announced it was recalling its Celltrion DiaTrust COVID-19 Ag Rapid Tests over concerns they can present test takers with a false positive result. 

Celltrion USA also initiated the recall over concerns the COVID-19 test kits were labeled to have a longer shelf life than what was authorized by the FDA. 

The company also initiated a recall last March for certain lots of its POC DiaTrust COVID-19 Ag Rapid Test kits that had been labeled for research use only. 

Celltrion USA conducted the recall after determining the COVID-19 tests had been distributed to consumers who it believed were unlikely to be using them for research and were not properly trained to safely conduct nasopharyngeal swab samples.

LuSys, Mesa Biotech COVID-19 test kits recalled over concerns

The FDA recalled COVID-19 Antigen tests in March 2022 that were manufactured by LuSys Laboratories after the agency determined the tests had not been authorized to be sold in the U.S. 

The FDA also determined the LuSys Laboratories COVID-19 tests, which were sold under various brand names, had not been verified to work accurately. 

Mesa Biotech, meanwhile, initiated a recall last May for its Accula SARS-CoV-2 Test kits over concerns that some of them carried an enlarged risk of providing a false positive test result.

The potential for an increased risk of a false positive test result was due to contamination at the manufacturing facility for the Accula SARS-CoV-2 Test kits. 

E25Bio accused of selling inaccurate COVID-19 test kits following recall

A class action lawsuit was filed against E25Bio Inc. in February 2022 by a consumer arguing the company sold direct antigen COVID-19 tests that were alleged to be inaccurate and falsely labeled as FDA-approved. 

The consumer behind the complaint argued the FDA had warned consumers not to use the E25Bio direct antigen COVID-19 tests, which the company is alleged to have marketed as being more accurate than a PCR test. 

“When Plaintiff purchased Defendant’s Covid Tests, Plaintiff did not know, and had no reason to know, that Defendant’s Covid Tests were not accurate, and were not authorized, cleared or approved by the FDA for distribution or use in the United States,” the E25Bio class action states. 

E25Bio recalled the direct antigen COVID-19 tests in January 2022 over concerns they could provide false results and were not authorized, cleared or approved by the FDA. 

Medtronic recalls delivery catheter systems over concerns they could break during surgery 

Medtronic initiated a recall in April 2022 for 665 of its Harmony Delivery Catheter Systems distributed in the U.S. between April 7, 2021, and Jan. 26, 2022, over concerns they could break during surgery. 

The recall was initiated after Medtronic discovered a bond holding a capsule at the end of the delivery catheter could break, leading to possible complications or harm to a patient. 

A total of six complaints from clinical cases had been reported in connection to the recall, in addition to one injury. 

Were you impacted by a medical device recall last year? Let us know in the comments.

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