The first half of 2023 has seen 19 medical device recalls. Here are the 10 biggest recalls listed in chronological order: 1. 2 deaths spur recall of 19.7M drug delivery devices Minneapolis-based ...13 June 2023

Getinge's business Maquet recalled all lots of about 20 oxygenators and cardiotomy reservoirs because of a potential sterility issue in the packaging.  The company said to continue using the affected ...12 June 2023

Abiomed removed 466 heart pumps from the market after customers complained about leaking fluid from the purge sidearm and three injuries were reported, the FDA said June 5.  The device, the Impella ...06 June 2023

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

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

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

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

... 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

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

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

... 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

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

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

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

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

... 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

... "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

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

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

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