23 Medical Supplies Recalled So Far in 2022

23 Medical Supplies

The Food and Drug Administration (FDA) is responsible for ensuring the safety of medical supplies & devices. It does this through a system of inspections, recalls, and other activities. In some cases, the FDA will issue a recall because they identify serious problems with a device that is likely to cause injury or death. In other cases, they may issue a recall because of a manufacturing defect or other problem that is not life-threatening but could lead to injury or property damage.

The FDA monitors report it receives from healthcare providers, manufacturers, and consumers. The agency then determines if there is a significant risk to patients and whether or not action should be taken.

What Is a Recall?

A recall is a voluntary action taken by a manufacturer or distributor to remove a product from the market because it may cause serious health problems or death. The Food and Drug Administration (FDA) can request that a company issue a recall, but it has no legal authority to order one.

Although recalls may be initiated by manufacturers, they are carried out by distributors, who are responsible for getting the affected product back to the company. Manufacturers are also required to notify FDA when they initiate a recall and provide copies of their letters to distributors.

Recalls are classified as Class I, II, or III based on the severity of the risk they pose:

Class I: A situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

According to this report, here is a list of 23 medical supplies & devices recalled in 2022 so far.

  1. FDA recalls illegally imported at-home COVID-19 tests

SD Biosensor at home COVID-19 tests was recalled since they were brought into the United States Illegally. This was a voluntary recall by SD Biosensor and no tests made it direct to the consumers.

  1. Empowered Diagnostics recalls more than 280K COVID-19 tests

Empowered Diagnostics did not receive FDA approval for their COVID-19 tests. It was determined their tests could produce false results.

  1. Philips Respironics recalls Trilogy ventilators, repair kits

A breakdown of polyester-based polyurethane foam caused Philips Respironics to recall 215 Trilogy Evo ventilators and 51 Trilogy Evo repair kits. Patients could be seriously injured or even die if black debris from the foam breakdown enters their airways.

  1. Medtronic recalls catheter used for blood flow procedures

The HawkOne Directional Atherectomy System has been recalled by Medtronic due to the risk of the guidewire descending when force is applied during use. Blood flow can be hindered if the catheter tip breaks off and tears or ruptures the wall of an artery.

  1. Getinge USA recalls vaporizer sevoflurane maquet filling

A potential breakdown of a surgical anesthetic chemical was reported in 50 units of Getinge’s vaporizer sevoflurane maquet filling, a component of its Flow Family Anesthesia Systems.

Eight consumer complaints were reported to the FDA, but no deaths or injuries were reported.

  1. Cardiovascular Systems recalls Wirion embolic protection devices

During procedures, Cardiovascular Systems has recalled 697 embolic protection devices that are part of catheters and are designed to remove blood clots and debris. There have been nine complaints about the filter breaking during retrieval, leading to the recall.

Neither injuries nor deaths were reported.

  1. Arrow International recalls more than 24K thrombolytic devices

Thrombolytic devices made by Arrow International have been recalled because the tip could detach from the catheter’s basket, resulting in serious injury or death.

There were 35 complaints reported to the FDA, 14 of which were injuries, and no deaths were reported.

  1. LuSys Laboratories recalls COVID-19 tests lacking FDA authorization

More than 150,000 nasal/saliva and antibody COVID-19 tests have been recalled by LuSys Laboratories because the FDA did not authorize the product.

The incident has not resulted in any injuries or deaths.

  1. E25Bio recalls unauthorized COVID-19 tests

About 70,000 antigen COVID-19 tests were recalled by E25Bio for a variety of reasons. Due to FDA non-authorization, the tests could produce false positives and false negatives. In addition, the label misidentified the product as FDA-authorized, when the FDA says only trained health care providers should collect these types of swab samples.

There were no deaths or injuries reported.

  1. BASE10 Genetics recalls nearly 500K specimen collection kits

More than 455,000 RNAstill MTM specimen collection kits have been recalled by BASE10 Genetics because they lack FDA approval. Nursing homes and other facilities with high-risk populations received the tests.

No injuries or deaths were reported by the FDA.

  1. Vyaire Medical recalls ventilators for failing to work

In response to reports of a software malfunction, Vyaire Medical has recalled 2,605 Bellavista 1000 and 1000e series ventilators.

18 complaints were reported to the FDA, seven injuries were reported, and there were no deaths reported.

  1. Family Dollar recalls products after rodent activity in the distribution center

The West Memphis, Ark.-based distribution center where Family Dollar manufactures drugs, devices, and other products have been recalled because of rodent infestations.

There were no injuries or deaths reported.

  1. SD Biosensor recalls illegally imported COVID-19 tests

After “confirmed reports that the test kits were illegally imported into the United States, SD Biosensor has recalled its Standard Q COVID-19 Ag Home Tests.

  1. Celltrion USA recalls COVID-19 tests because of too many false positives

There has been a recall of 45,500 units of the DiaTrust COVID-19 Ag Rapid Test by Celltrion USA due to a high number of false positive results and incorrect labeling on the product, which states that the shelf life is 18 months, when the FDA has capped the shelf life of COVID-19 tests at 12 months as part of its emergency use authorization.

  1. Baxter recalls infusion pumps because of alarm failure

A software issue could result in the Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) and SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) being recalled by Baxter.

There have been 51 serious injuries and three deaths “possibly associated with this issue,” according to the company.

  1. Acon Laboratories recalls counterfeit, unauthorized COVID-19 tests

The FDA has not authorized Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) by Acon Laboratories, and it cannot be distributed.

  1. Karl Storz recalls urological endoscopes

As a result of concerns about the efficacy of the manual high-level disinfection process, Karl Storz is recalling several cystoscopes, ureteroscopes, cystourethroscopes, and ureterorenoscopes.

  1. Abbott recalls nearly 5K imaging catheters

As a result of proximal marker loosening and breaking off during procedures, Abbott has recalled 4,800 Dragonfly OpStar imaging catheters.

A total of five incidents have been reported by the FDA, one injury has been reported, and there has been no death reported.

  1. Philips Respironics recalls ventilators due to power issues

A power issue may prevent Philips Respironics from sounding the alarm before shutting off 56,671 V60 and V60 Plus Ventilators.

Four people have been injured and one person has died as a result of this issue, according to the FDA.

  1. Medtronic recalls heart medical devices, citing a pump weld defect

A welding defect has caused Medtronic to recall 1,614 HeartWare Ventricular Assist Device Systems due to corroding internal magnets and causing the pump to rotate incorrectly.

According to the FDA, two people have been injured and one person has died because of the device issue.

  1. Baxter recalls Volara devices due to risk of oxygen loss

After one at-home patient-reported oxygen desaturation, Baxter recalled its Volara System.

  1. Draeger recalls more than 35K breathing system filters

Several lots of Draeger’s SafeStar 55 Breathing System Filter were defective, resulting in serious injuries or deaths.

Injuries have been reported to the FDA, but no deaths have been reported.

  1. BD recalls bone marrow devices

An intraosseous needle set kit, a manual driver kit, and a powered driver have been recalled by Becton Dickinson and Co. due to sticking issues.

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