November 19, 2025Medical DevicesFDA
TECHNO-PATH MANUFACTURING LTD. recalls Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control se
Hazard: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
November 19, 2025Medical DevicesFDA
Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl
Hazard: Due to an device without a premarket clearance being incorrectly package and distributed.
November 19, 2025Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T
Hazard: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
November 19, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
Hazard: The nasal feeding tube may be occluded
November 19, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
Hazard: The nasal feeding tube may be occluded
November 19, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
Hazard: The nasal feeding tube may be occluded
November 19, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
Hazard: The nasal feeding tube may be occluded
November 19, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Hazard: The nasal feeding tube may be occluded
November 19, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Hazard: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
November 19, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci
Hazard: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
November 19, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Hazard: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
November 19, 2025Medical DevicesFDA
Stryker Sustainability Solutions recalls HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STER
Hazard: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
November 19, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.
Hazard: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
November 19, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Hazard: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
November 19, 2025Medical DevicesFDA
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06
Hazard: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
November 19, 2025Medical DevicesFDA
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Hazard: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
November 19, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Hazard: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
November 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi
Hazard: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
November 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal
Hazard: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
November 19, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th
Hazard: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
November 19, 2025Medical DevicesFDA
NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Hazard: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
November 19, 2025Medical DevicesFDA
Miach Orthopaedics recalls BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Hazard: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
November 19, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
Hazard: Polyaxial screws do not meet performance standards.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or low
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
November 19, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15
Hazard: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.