Boston Scientific Recalls OverStitch Suture Cinch Over Deployment Failure Risk
FDA classifies recall of endoscopic tissue approximation device as Class II due to potential failure to deploy cinch or cut suture.
Recalls & Safety Alerts in Massachusetts
Every recalls & safety alerts report published for Massachusetts, newest first.
FDA Class II Recall of Siemens Beckman Coulter Quinidine Assay Kits: Check Your Lots
The FDA has classified the recall of certain lots of the Emit 2000 Quinidine Assay as Class II, and is urging users to check their inventory against the listed lots and UDI.
Paragonix Technologies Recalls KidneyVault Systems Over Firmware Defect
FDA classifies recall of 1,445 portable renal perfusion systems as Class II due to potential loss of displayed preservation parameters.
Siemens Healthcare Diagnostics Recalls Quinidine Assay Kits Over Precision Concerns
FDA classifies recall of Syva EMIT 2000 Quinidine Assay as Class II due to risk of elevated measurements.
FDA Closes Class I Recall of Spectra Medical Devices Sodium Chloride Injection
The FDA has closed the recall of Spectra Medical Devices' Sodium Chloride Injection, 0.9%, USP 10mL Ampule, citing completed corrective actions.
FDA Reports Class II Recall of Straumann Dental Implants Over Mislabeled Length
The FDA has reported a Class II recall of certain Straumann Bone Level Tapered implants that may be shorter than labeled, as of August 19, 2026.
FDA Classifies Recall of GEM Premier 7000 Blood Analyzers as Class II Hazard
FDA enforcement records show an ongoing recall of four GEM Premier 7000 portable blood analyzers due to barcode reader wand issues.
FDA Enforcement Records Detail Class II Recall of Philips CT Scanners
The ongoing recall covers 42 IQon Spectral CT units and upgrades distributed across the United States and Puerto Rico.
FDA Closes Recall Action for GEM Premier 5000 Blood Analyzer Systems
The agency considers the recall of 67 portable blood analyzer systems carried out.
FDA Closes Recall Action for GEM Premier 5000 Blood Analyzer Systems
The agency considers the recall carried out for 27 blood analyzer units involved in a barcode reader identification issue.
FDA Classifies Recall of GEM Premier 5000 Blood Analyzers as Class II
The FDA classified the recall of 21 GEM Premier 5000 blood analyzer systems as Class II on August 5, 2026.
FDA Reports Ongoing Class II Recall of GEM Premier 5000 PAK Units
Instrumentation Laboratory has recalled 109 units of GEM Premier 5000 PAK due to solution concentration issues.
FDA Reports Ongoing Recall of CHEER PACK Food Pouches Distributed in Oregon
An ongoing Class II recall covers 322,450 flexible food pouches that may release thin plastic strips into food puree.
FDA Reports Class II Recall of Boston Scientific Biopsy Forceps
Boston Scientific Corporation initiated an ongoing recall for thousands of biopsy forceps due to a potential packaging breach.
FDA Records Class I Recall of Abiomed Impella CP Pump Sets Over Introducer Leak Risk
An FDA enforcement report covering 87,277 units cites potential introducer sheath leakage that the record says is not visually detectable by users.
FDA classifies Abiomed Impella CP introducer kit recall as Class I
An enforcement report covering 846 units of the 14 Fr introducer kit cites a potential for sheath leakage that the record says is not visually detectable by users.
FDA Classifies Abiomed Impella CP Introducer Kit Recall as Class I
An FDA enforcement report lists 1,540 units of the 14 Fr introducer kit recalled worldwide over a potential sheath leakage issue that the record says is not visible to users.
Boston Scientific Recalls Rapid Refill Continuous Injection System Over Syringe Disconnection Risk
An FDA enforcement report classifies the ongoing Class II recall of more than 150,000 US units of the endoscopy injection set, citing a recalled component syringe that may loosen from the manifold.