Medical Device Recall

Nearly 100,000 bottles of nasal spray recalled for 'microbial failure'

Almost 100,000 bottles of nasal spray were recalled for a "microbial failure" that led to multiple complaints from customers.

MassLive · 2d

FDA recalls 90K bottles of nasal spray due to potential ‘adverse’ effects: Throw out ASAP

The recalled products were sold across 32 states — including Massachusetts, Connecticut, Rhode Island and Vermont.

NJ.com on MSN · 3d

FDA recalls over 89K bottles of nasal spray that may cause ‘adverse’ medical effects during flu season, throw out ASAP

If you suffer from allergies or sinus congestion, you might want to think twice before using this nasal spray. The U.S. Food and Drug Administration is recalling 89,312 bottles of NasoGel nasal spray because the product might cause “adverse” medical effects.

Staten Island Advance · 2d

Don’t use this nasal spray: FDA says it may cause ‘adverse’ effects

The U.S. (FDA) has announced a recall of 89,312 bottles of a popular nasal spray that may cause “adverse” effects. The NasoGel was recalled by the manufacturer, NeilMed Pharmaceuticals Inc., the FDA said.

Hosted on MSN6mon

The FDA calls them "recalls," yet the targeted medical devices often remain in use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious ...

MassDevice1d

J&J’s Abiomed updates Impella RP instructions in Class I recall

The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson Abiomed Impella RP heart ...

Becker's Hospital Review1mon

3 medical device recalls

Medical device recalls, whether voluntary or mandated, are crucial for ensuring patient safety. Here are three recent recalls reported to the FDA: Phillips recalls monitoring service ...

Hosted on MSN4d

FDA tags Sentec/Percussionaire’s breathing circuit recall as Class I

The US Food and Drug Administration (FDA) has tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as ...

MassDevice8d

Medline has a Class I arterial catheter recall

The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall.

Becker's Hospital Review8d

4 recent medical device recalls and corrections

JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...

BioWorld1mon

FDA provides glossary for medical device recalls

Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal.

pharmaphorum15d

Device ad-vice: Best practices for handling a medical device recall

On the bright side, AdvaMed, a global device manufacturer advocacy organization, recently stated that less than one percent of devices cleared since 1998 were involved in Class I recalls 5.

HME News9d

Urgent recall issued for TrueAire-5 oxygen concentrator

The U.S. Food and Drug Administration has issued an urgent recall for the JMCC5A Ni/TruAire-5 Oxygen Concentrator due to the device spontaneously catching fire.

MedPage Today20d

Limbo of Cardiac Device Recalls Has Physicians Ready for Change

A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device design (31.4%), process control (16.1%), or component design or ...

‘The foam inside breaks down’: Man warns Philips CPAP machines are still out in circulation despite recall. Here’s why you should be careful

Nicko displays the device, a Philips DreamStation, to the camera, noting that it has “now been recalled.” He claims this is because the sound-abating foam inside breaks down, “and then it travels into ...

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