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FDA warning letters, drug approvals, ICH guidelines, EMA updates, and DEA scheduling.
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Healthcare Compliance
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Trade & Procurement
Recent changes
Tony L. Ware v. Fidelity Acceptance Corporation - Dismissal for Lack of Jurisdiction
The Georgia Court of Appeals dismissed Tony L. Ware's appeal against Fidelity Acceptance Corporation for lack of jurisdiction. The trial court had corrected a clerical error under OCGA § 9-11-60(g) but left issues pending, making the order non-final and the direct appeal premature. The court cited precedent requiring interlocutory application procedures for such orders.
Orthalign Drill Plate Recall - Bone Cuts Exceed Specification
FDA issued a Class II medical device recall for Orthalign, Inc.'s Drill Plate, Ortho Dev. Trimax - Pegged (REF:402566), a component of the Lantern Knee System. The recall affects products manufactured out of specification that may result in bone cuts exceeding 0.0800 inches (2.8448mm). Distribution is nationwide with presence in Utah.
I.T.S. GmbH Headless Compression Screw MRI Safety Recall
FDA initiated a Class II recall (Z-1606-2026) for I.T.S. GmbH's Headless Compression Screw System due to updated MRI safety testing revealing higher RF-induced temperature increases under certain MRI conditions than previously documented in the Instructions for Use. The recall affects multiple article numbers distributed nationwide across multiple US states. Healthcare providers and distributors should immediately identify affected inventory and halt use pending updated guidance.
Olympus PKS Cutting Forceps Recall - Welding Defect
Olympus Corporation of the Americas issued a Class II device recall for PKS Cutting Forceps (Model/Catalog Number: 3005PK) due to inadequate supplier welding process validation. The defective welds can cause the forceps' jaw to break during clinical use, posing a safety risk to patients. Healthcare providers using these devices should immediately identify and remove affected units from service.
BD Alaris System Recall - TLS Labeling Security Issue
FDA issued Class II recall Z-1645-2026 for BD Alaris System with Guardrails Suite MX with Point of Care Unit manufactured by CareFusion 303, Inc. The recall addresses missing product labeling specifying which TLS version must be enabled on hospital networks for secure Wi-Fi communication. Affected devices were distributed nationwide in the U.S. across multiple states.
Tandem Insulin Pump Recall - Czech Language User Guide Translation Errors
FDA initiated a Class II recall (Z-1636-2026) of Tandem Diabetes Care insulin pumps due to translation errors in Czech language user guides distributed in Czech Republic and Slovakia. The critical error instructed users to verify the infusion set IS connected to the body when users should confirm it is NOT connected. The recall is ongoing as of April 1, 2026.
Olympus MAJ-1443 Endoscope Suction Valve Recall - Reprocessing Incompatibility
Olympus Corporation of the Americas issued a Class II recall for MAJ-1443 Endoscope Suction Valves. The recall addresses compatibility issues where MAJ-1443 and MAJ-1444 valves no longer work with OER-Pro and OER-Elite automated endoscope reprocessors. Distribution covers US Nationwide.
GE Medical Imactis CT-Navigation System Recall - Discordant Needle Trajectory
FDA announced Class II recall of GE Medical Systems' Imactis CT-Navigation System due to potential discordance between simulated and actual needle trajectory/tip position. The recall affects Model Numbers E85101LA and E85101LP distributed nationwide. Healthcare providers using these systems should review and follow manufacturer's corrective instructions.
Medtronic MiniMed 780G Software Defect Recall - Hypoglycemia Risk
The FDA initiated Class II recall Z-1635-2026 for Medtronic MiniMed 780G insulin pumps (models MMT-1884, MMT-1886) with Software versions 6.60 and 6.61. Three software defects (Pump Error 53, BG check, and Critical Pump Error) may cause inaccurate insulin delivery, creating hypoglycemia or hyperglycemia risk. The recall affects devices distributed nationwide across all U.S. states and is ongoing.
QOZ Census Tract Nomination Procedures Under One, Big, Beautiful Bill
The IRS and Treasury Department issued Revenue Procedure 2026-14 establishing the nomination process for Qualified Opportunity Zones under the One, Big, Beautiful Bill, which permanently extends the QOZ tax incentive. The guidance identifies 25,332 eligible low-income census tracts, of which 8,334 are entirely rural areas. State CEOs may begin nominating tracts on July 1, 2026, with designations effective January 1, 2027.
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