September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
September 10, 2025Medical DevicesFDA
CARIS LIFE SCIENCES recalls MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t
Hazard: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
September 10, 2025Medical DevicesFDA
O&M HALYARD INC recalls Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Hazard: Surgical drape packs may have open seals, which may compromise the sterility of the product.
September 10, 2025Medical DevicesFDA
Lumicell, Inc. recalls Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper
Hazard: The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
September 10, 2025Medical DevicesFDA
Merge Healthcare, Inc. recalls Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M
Hazard: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
September 10, 2025Medical DevicesFDA
Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalls FloPatch FP120, REF: FP120-FOT01-005
Hazard: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
September 10, 2025Medical DevicesFDA
PREMIA SPINE LTD recalls TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Hazard: Potential for missing pins at tip of inserter.
September 10, 2025Medical DevicesFDA
Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative i
Hazard: Due to a risk of false positive results that could lead to unnecessary medical treatment.
September 10, 2025Medical DevicesFDA
Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Hazard: Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
September 10, 2025Medical DevicesFDA
Medshape, INC. recalls Medshape Universal Joints, REF: DNE-9000-UJ
Hazard: Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Descr
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDI
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model
Hazard: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre
Hazard: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp
Hazard: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
September 10, 2025Medical DevicesFDA
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str
Hazard: Due to products distributed without premarket clearance or approvals.
September 10, 2025Medical DevicesFDA
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str
Hazard: Due to products distributed without premarket clearance or approvals.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Hazard: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RaySta
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.