Here are 23 medical supply recalls Becker's Hospital Review has reported on this year:
1. FDA recalls illegally imported at-home COVID-19 tests
The FDA has recalled COVID-19 tests imported by SD Biosensor because of confirmed reports they were illegally imported to the U.S. SD Biosensor voluntarily recalled the tests that had "no known distribution of these tests directly to consumers."
2. Empowered Diagnostics recalls more than 280K COVID-19 tests
Empowered Diagnostics has recalled about 286,675 COVID-19 tests because they lacked FDA approval, which the regulator said could lead to false results. There have been no reports of adverse effects from the CovClear COVID-19 tests.
3. Philips Respironics recalls Trilogy ventilators, repair kits
Philips Respironics recalled 215 Trilogy Evo ventilators and 51 Trilogy Evo repair kits with the most serious type of recall because of a breakdown of a polyester-based polyurethane foam. Black debris from the foam breakdown can accidentally enter patients' airways and could lead to serious injury or death.
4. Medtronic recalls catheter used for blood flow procedures
Medtronic has recalled more than 95,000 units of HawkOne Directional Atherectomy System because of the risk of guidewire within the catheter descending when force is applied during use. If the tip of the catheter breaks off, the wall of an artery can be torn or ruptured and hinder blood flow.
5. Getinge USA recalls vaporizer sevoflurane maquet filling
Getinge has recalled 50 units of its vaporizer sevoflurane maquet filling, a component of the company's Flow Family Anesthesia Systems, after reporting a potential breakdown of a surgical anesthetic chemical that can cause serious injury. The FDA reported eight consumer complaints and no deaths or injuries.
6. Cardiovascular Systems recalls Wirion embolic protection devices
Cardiovascular Systems has recalled 697 units of its embolic protection devices, which is part of a catheter and is intended to remove blood clots and debris during procedures. The recall comes after nine complaints reporting the filter breaking during retrieval. No injuries or deaths were reported.
7. Arrow International recalls more than 24K thrombolytic devices
Arrow International has recalled 24,895 thrombolytic devices used to remove blood clots because of the risk of the tip detaching from the catheter's basket, which could result in serious injury or death. The FDA reported 35 complaints, which included 14 injuries and no deaths.
8. LuSys Laboratories recalls COVID-19 tests lacking FDA authorization
LuSys Laboratories has recalled more than 150,000 nasal/saliva and antibody COVID-19 tests because the FDA did not authorize the product. There have been no reported injuries or deaths.
9. E25Bio recalls unauthorized COVID-19 tests
E25Bio recalled about 70,000 antigen COVID-19 tests for several reasons. First, the FDA did not authorize the product, so the tests could result in false positives and false negatives. Second, the labeling instructed users to perform the tests on themselves, which the FDA said "only trained health care providers should collect these types of swab samples." And third, the label misidentified the product as FDA-authorized. No deaths or injuries were reported.
10. BASE10 Genetics recalls nearly 500K specimen collection kits
BASE10 Genetics has recalled more than 455,000 RNAstill MTM specimen collection kits because the product lacked FDA authorization. The tests were sent to nursing homes and other facilities with high-risk populations. The FDA reported no injuries or deaths.
11. Vyaire Medical recalls ventilators for failing to work
Vyaire Medical has recalled 2,605 Bellavista 1000 and 1000e series ventilators after reports of a software malfunction prompting the device to not ventilate and inciting a technical failure alarm. The FDA reported 18 complaints, seven injuries and no deaths.
12. Family Dollar recalls products after rodent activity in distribution center
Family Dollar has recalled drugs, devices and other products manufactured in a West Memphis, Ark.-based distribution center due to the presence of rodents. No injuries or deaths were reported.
13. SD Biosensor recalls illegally imported COVID-19 tests
SD Biosensor has recalled its Standard Q COVID-19 Ag Home Tests after "confirmed reports that the test kits were illegally imported into the United States." The product was not authorized by the FDA.
14. Celltrion USA recalls COVID-19 tests because of too many false positives
Celltrion USA has recalled 45,500 units of its DiaTrust COVID-19 Ag Rapid Test product due to a "high number" of false positive results and incorrect labeling that stated the shelf life is 18 months when the FDA's emergency use authorization has capped the shelf life for COVID-19 tests at 12 months.
15. Baxter recalls infusion pumps because of alarm failure
Baxter has recalled 277,450 infusion pumps, the SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9), because of a software issue that could lead to the alarm not working. The company has reported 51 serious injuries and three deaths "potentially associated with this issue."
16. Acon Laboratories recalls counterfeit, unauthorized COVID-19 tests
Acon Laboratories has recalled its COVID-19 tests, labeled Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), because the FDA did not authorize the antigen test and cannot be distributed.
17. Karl Storz recalls urological endoscopes
Karl Storz has recalled various cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes because the efficacy of the "manual high-level disinfection process cannot be assured," the company said.
18. Abbott recalls nearly 5K imaging catheters
Abbott has recalled 4,800 Dragonfly OpStar imaging catheters due to proximal marker, which is furthest from the catheter's tip, loosening and breaking off during procedures. The FDA has reported five incidents, one injury and no deaths related to the issue.
19. Philips Respironics recalls ventilators due to power issues
Philips Respironics has recalled all 56,671 V60 and V60 Plus Ventilators because of a power issue that could prevent the alarm from sounding before shutting off. The FDA has reported four injuries and one death associated with the issue.
20. Medtronic recalls heart medical devices, citing a pump weld defect
Medtronic has recalled 1,614 HeartWare Ventricular Assist Device Systems after an analysis showed a welding defect that could corrode the internal magnets and cause the pump to rotate incorrectly. There have been two injuries and one death regarding the device issue, according to the FDA.
21. Baxter recalls Volara devices due to risk of oxygen loss
Baxter has recalled its Volara System because of a possible risk of oxygen desaturation after one at-home patient filed a report.
22. Draeger recalls more than 35K breathing system filters
Draeger one lot of its SafeStar 55 Breathing System Filter due to defective, "partially obstructed" filters, which can result in serious injury or death. The FDA has reported one injury and no deaths.
23. BD recalls bone marrow devices
Becton, Dickinson and Co. has recalled 67 lots of intraosseous needle set kits, manual driver kits and powered drivers due to sticking issues within the product.