Tag: class_i_recall

FDA Announces Class I Recall for BMC Luna G3 APAP Due to Firmware Flaw

8 Sep 2026 4:53 p.m. · Source: US Food and Drug Administration

BMC Medical's Luna G3 APAP devices face a Class I recall due to a firmware defect. The flaw can cause therapy failure, potentially leading to serious health consequences, with up to 196 units possibly still affected.

Health Business Science & Technology Medical Science Computers and Internet Legal Product Recall Medical Devices FDA BMC Medical Co., Ltd.Luna G3 APAP Firmware Defect Class I Recall Food Recalls Drugs
FDA Issues Class I Recall for Boston Scientific Spinal Cord Stimulator Leads

3 Sep 2026 4:18 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's unused Infinion CX Leads, part of Spinal Cord Stimulator Systems. Mechanical stress can cause lead fractures, leading to inadequate stimulation and 1,081 reported serious injuries. This recall affects only…

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AVID Medical Issues Class I Recall for Kits with Contaminated Medline Manifolds

27 Aug 2026 12:22 p.m. · Source: US Food and Drug Administration

AVID Medical has issued a Class I recall for convenience kits containing Medline Namic Star Off Handle Manifolds due to particulate contamination. The FDA warns of serious injury or death if these components are not removed, though no incidents have…

Health Business Medical Science Federal Government Legal AVID Medical Medline Namic Star Off Handle Manifolds Class I Recall FDA Product Recall Medical Devices Food Recalls Drugs
FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

26 Aug 2026 11:16 a.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's ENROUTE Transcarotid Neuroprotection System and Plus, citing potential for serious injury or death. This urgent action requires removal of affected percutaneous catheters from use.

Health Business Politics and Government Medical Science Federal Government Legal Product Recall Medical Device Boston Scientific FDA ENROUTE Transcarotid Neuroprotection System Class I Recall Percutaneous Catheter Food Recalls Drugs
Medline Issues Class I Recall for Kits with Compromised Anesthetic

20 Aug 2026 6:02 p.m. · Source: US Food and Drug Administration

Medline has initiated a Class I recall for convenience kits containing B. Braun components with Huons Bupivacaine Hydrochloride. This correction addresses serious risks like infection and reduced anesthetic effectiveness, urging customers to remove affected parts.

Health Business Law Enforcement Medical Science Legal Social Issues Education Medline B. Braun Huons Bupivacaine Hydrochloride Class I Recall Medical Devices Product Recall FDA Food Recalls Drugs
Medline Issues Class I Recall for Anesthetic Injections in Convenience Kits

3 Aug 2026 5:13 p.m. · Source: US Food and Drug Administration

Medline is correcting convenience kits by removing Huons Lidocaine and Bupivacaine injections. The FDA identified this as a Class I recall due to quality issues, posing risks of ineffective pain control. No injuries reported as of May 20.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues FDA Medline Huons Lidocaine Hydrochloride Bupivacaine Hydrochloride Class I Recall Product Recall Food Recalls Drugs
Bolton Medical Issues Class I Recall for Relay Pro Thoracic Stent Graft System

17 Jul 2026 12:23 p.m. · Source: US Food and Drug Administration

Bolton Medical has initiated a Class I recall for its Relay Pro Thoracic Stent Graft System (N4: Non-Bare Stent Configuration 32mm and above) due to a critical issue where the graft may fail to unclasp, potentially leading to patient death…

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FDA Issues Class I Recall for Medtronic Harmony Delivery Catheter System

13 Jul 2026 3:19 p.m. · Source: US Food and Drug Administration

Medtronic's Harmony Delivery Catheter System faces a Class I recall by the FDA due to a risk of distal tip detachment. This serious issue could require secondary intervention and poses significant patient risks, though no serious injuries or deaths are…

Health Business Politics and Government Medical Science Federal Government Legal Medtronic Harmony Delivery Catheter System Product Recall FDA Medical Device Class I Recall Pulmonary Valve Food Recalls Drugs
FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers

22 Jun 2026 11:24 a.m. · Source: US Food and Drug Administration

The FDA has upgraded an alert for Abiomed's Automated Impella Controllers to a Class I recall, the most serious type, following two injuries and one death. The recall focuses on updated usage instructions to prevent serious harm, not device removal.

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KayserBetten Issues Urgent Correction for IDA Pediatric Care Beds Amid Serious Injury Risk

30 May 2026 7:07 a.m. · Source: US Food and Drug Administration

KayserBetten is correcting its IDA pediatric care beds due to a serious entrapment risk, identified as a Class I recall. A free hand control replacement with automatic locking will be provided to prevent injury or death.

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FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks

26 May 2026 1:56 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Medline Namic Manifolds and related kits due to particulate in the fluid path. This poses a serious risk of injury or death if introduced into blood circulation, prompting immediate removal of…

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