Recalls — last 90 days
- 2026-07-08FDA-DeviceSiemens Medical Solutions USA, IncClass IIARTIS icono ceiling. Model Number: 11328100.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-07-08FDA-DeviceSiemens Medical Solutions USA, IncClass IIARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-07-08FDA-DeviceAccuray IncorporatedClass IICyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
- 2026-07-08FDA-DeviceTELEFLEX LLCClass IIBrand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical si
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
- 2026-07-08FDA-DeviceBaxter Healthcare CorporationClass IIAdapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceBoston Scientific CorporationClass IICRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-08FDA-DeviceHamilton Medical AGClass IIIntelliCuff, Portable automatic cuff pressure controller REF: 951001
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
- 2026-07-08FDA-DeviceMedtronic Heart Valves DivisionClass IMedtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- 2026-07-08FDA-DeviceRemel, IncClass IIGC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
- 2026-07-08FDA-DeviceWindstone Medical Packaging, Inc.Class IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceWindstone Medical Packaging, Inc.Class IA M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceWindstone Medical Packaging, Inc.Class IA M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceWindstone Medical Packaging, Inc.Class IA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- 2026-07-08FDA-DeviceMedacta Usa IncClass IIShort Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
- 2026-07-08FDA-DeviceDEPUY (IRELAND)Class IIDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- 2026-07-08FDA-DeviceDEPUY (IRELAND)Class IIDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Numbe
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- 2026-07-08FDA-DeviceMedline Industries, LPClass IReprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- 2026-07-08FDA-DeviceMentor Texas LPClass IISYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
A single lot of expired syringes were distributed due to a distribution system control failure.
- 2026-07-08FDA-DeviceMedline Industries, LPClass IIMedline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.