Medical Devices and Pharma
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FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...
How to Know if Internet GLP-1 Ads Are Safe to Purchase Online
Ads for GLP‑1 drugs are flooding the internet – here’s how to know if it’s safe to buy them online Websites that sell compounded versions of GLP-1 drugs are not allowed to sell them under the brand names. Michael Siluk/UCG, Universal Images Group via Getty Images...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug Administration’s recent approval of leucovorin (Wellcovorin) for cerebral folate transport deficiency caused by FOLR1 gene variants highlights an...
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Abbott Hit with $70 Million Verdict from Infant Formula Litigation
Neonatal nutritional product litigationJury findings raise new questions about risk communication, labeling, and regulatory expectations for neonatal nutrition products A Chicago jury has ordered Abbott Laboratories to pay $70 million in damages after finding that its...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
Tippy Toes Apple Pear Banana Baby Food Recalled
Baby Food Recalled for Elevated Patulin Levels Recall Date: February 13, 2026Company: IF Copack LLC d.b.a. Initiative FoodsBrand: Tippy ToesProduct Type: Baby Food Fruit PuréeHazard: Elevated levels of patulin (a mycotoxin) Initiative Foods has issued a voluntary...
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S....
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA)...
Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain...
Infant Formula Recalled after Reports of Botulism
Three Infants Hospitalized; Nationwide Recall Initiated Nara Organics has voluntarily recalled all lots of its powdered...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
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