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61. Spring 2022 saw most recalled medical devices amid pandemic: Report
With 268 recalls, the second quarter of 2022 hit the record of the highest number of recalled medical devices since 2020, according to an industry report from Sedgwick. In the second quarter of 2022, ...30 May 2023 -
62. Teva recalls 13 lots of fentanyl products
Teva Pharmaceuticals recalled 13 lots of fentanyl buccal tablets, a Type II substance, because of omitted safety updates on its medication guide, the FDA said April 28. The agency said the main concern ...28 April 2023 -
63. Closed drugmaker recalls all lots of 84 drugs because of quality risk
Akorn Operating Co., a Gurnee, Ill.-based drugmaker that closed all operations in late February, issued a nationwide recall of all lots of 84 drugs it made because the shutdown discontinued its quality ...26 April 2023 -
64. Fresenius Kabi recalls drug infusion pumps with leak risk
Fresenius Kabi USA recalled 1,546 large infusion pumps in a Class I recall, the most serious type, because of a risk of leaking products entering the electrical system and shutting down the device. The ...20 April 2023 -
65. Philips recalls more sleep apnea machines
... over the issue. No deaths or injuries have been reported. Philips has issued several recalls involving its ventilation devices in recent years. The company recalled about 3.5 million devices in June 2021 ...10 April 2023 -
66. Camber recalls 1 lot of pneumonia drug because of microbial contamination
Camber Pharmaceuticals recalled one lot of a drug for pneumocystis jiroveci pneumonia because of the contamination risk of Bacillus cereus. The microbial contaminant risk in Camber's atovaquone oral ...06 April 2023 -
67. 6 recent FDA recalls, warnings, approvals
Here are six FDA recalls, approvals and warnings Becker's has covered since Feb. 24: FDA clears thinner nitrile gloves made by Ochsner's supply company FDA recalls 2K Datascope heart balloon pumps ...24 March 2023 -
68. Dr. Stacy Nicholson, President of Children's Service Line and Chair of Pediatrics at Atrium Healt
... significantly. Dr. Nicholson recalls that when she first started, pediatric care mainly focused on treating infectious disease illnesses. However, over time, pediatrics became specialized, and the focus ...22 March 2023 -
69. FDA recalls 2K Datascope heart balloon pumps
More than 2,000 heart balloon pumps are part of a Class I recall issued by the FDA. The two models being recalled — Cardiosave Hybrid and Rescue pumps made by Datascope, a subsidiary of Getinge — have ...22 March 2023 -
70. Philips recalls 13K reworked ventilators
Philips Respironics recalled 13,811 ventilators the company reworked or replaced after it pulled millions of them off the market in summer 2021. The devices — Trilogy 100, Trilogy 200, and Garbin ...20 February 2023 -
71. GE HealthCare recalls body scanners over risk of trapping, crushing patients
GE HealthCare issued a recall of 688 of its Nuclear Medicine 600/800 Series Systems after identifying an issue that could lead to the machine's detector falling and trapping or crushing a patient. In a ...17 February 2023 -
72. 8 recent drug, device recalls
Here are eight drug and medical device recalls the FDA recently reported: 1. GE Healthcare recalls 7.5K oxygen monitors GE Healthcare recalled 7,559 TruSignal sensors — which track arterial oxygen ...27 January 2023 -
73. Recalled heart device tied to 1 death, 4 serious injuries, FDA says
... also face a potential biohazard risk. The FDA's class 1 recall notice comes after Swedish medical device-maker Getinge issued two other recalls related to this device in 2022. The first recall of ...26 January 2023 -
74. Unsafe medical devices make it to market without testing, Yale study finds
... "loophole" approvals has been based on medical devices that later were recalled. These include Class I recalls where the FDA concluded using the device could cause harm or death. Moreover, the newly authorized ...20 January 2023 -
75. 2 studies note potential flaws in FDA device approvals
More than 2 in every 5 medical devices the FDA authorized with the 510(k) pathway had predicates that were Class I recalls — the most serious type of recall — according to a study published Jan. 10 in ...11 January 2023 -
76. 6 nitrosamine drug recalls in 2022
Since 2019, the FDA has reported dozens of drug recalls because of the presence of nitrosamine, a probable carcinogen that largely pulls blood pressure treatments off the market. Lawsuits against ...28 December 2022 -
77. 8 recent drug, device recalls
Here are eight drug and medical device recalls the FDA reported in December: 1. Dewei Medical Equipment pulled 250,000 DNA/RNA preservation kits off the market in a class 1 recall — the most serious ...27 December 2022 -
78. 4 device recalls in November
Here are four medical device recalls the FDA reported in November: Note: There were no drug recalls in November, according to the FDA's website. 1. Baxter Hillrom recalls 8.5K bedpans Baxter Hillrom ...28 November 2022 -
79. 7 recent drug, device recalls
Here are seven drug and medical device recalls the FDA reported in October: 1. Golden State Medical Supply recalled one lot of its clopidogrel tablets and one lot of atenolol tablets because of a ...26 October 2022 -
80. Philips Respironics recalls 1M more sleep masks
Since their September recall of more than 17 million sleep masks, Philips Respironics bumped that number up to 18,670,643 units on Oct. 19. The devicemaker recalled five types of their BiPAP and CPAP ...19 October 2022