10 biggest medical device recalls in 2023

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 Smiths Medical recalled nearly 20 million medical devices after two deaths, 25 injuries and 10,672 incidents were reported, the FDA said Feb. 2. 

In a Class I recall — the most serious type — more than 19.7 million Continuous Ambulatory Delivery Device administration sets and medication cassette reservoirs were pulled from the market in December for two potential issues. A tubing blockage that could stop or under-deliver medication has been tied to two deaths, 14 injuries and 1,571 incidents.

2. 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 Feb. 15 statement, the FDA classified this as a Class I recall because the faulty machines could result in serious injury or death.

3. 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 altered devices were recalled because foam could break away from the plastic backing and block the airpath, which can cause serious injury or death. 

There have been no deaths reported, and 82 medical device reporting complaints were filed.

4. FDA expands recall of eye products tied to bacterial infections

The FDA expanded its recall for eye drops potentially contaminated with a highly drug-resistant bacteria that has hospitalized 16 and blinded six patients. One person died after the bacterial infection spread to their bloodstream. 

5. 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 been reported to unexpectedly shut down due to a malfunction of a coiled cable that connects the display to the device's base. There is one death and 71 complaints tied to the recall.

6. FDA, Abbott warn 4.2M glucose devices may be affected by fire risks

Days after medical device company Abbott issued a voluntary safety warning for its glucose monitoring devices, the FDA published a recall note April 6 stating that more than 4 million of the company's FreeStyle Libre readers may be prone to an issue with the lithium-ion battery that can cause extreme cases of overheating.

Although the FDA noted this is a Class I recall, none of Abbott's physical readers are actually being recalled, a spokesperson for Abbott clarified to Becker's via email.

7. 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. 

As of April 19, there are 14 complaints, zero injuries and zero deaths related to this recall, according to the FDA.

8. 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 measures. 

The company asked for customers to identify and destroy 51 human and 33 animal drug products, according to an April 26 post from the FDA.

9. 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 with the excluded safety update is it "could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote."

10. 570K breathing circuits, anesthesia kits recalled

Draeger Medical, or Dräger US, recalled more than half a million airway devices because of a manufacturing error that can lead to hypoxia and death, the FDA said May 24. 

The Class I recall includes Seattle-Positive Airway Pressure Plus systems and 21 other breathing circuits and anesthesia kits. Draeger alerted customers in mid-April of a risk of glued components separating and interrupting airflow, according to the agency.

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