FDA Medical Device Recalls

Open, ClassifiedPosted Feb 27, 2026·Initiated Jan 20, 2026

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

Reason: Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.

Root cause: Software design

Recalling firm: Roche Diagnostics Operations, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US Nationwide distribution.Recall #Z-1476-2026

Open, ClassifiedPosted Feb 27, 2026·Initiated Nov 14, 2025

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Root cause: Device Design

Recalling firm: Olympus Corporation of the AmericasType: Lithotriptor, UltrasonicDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.Recall #Z-1477-2026

Open, ClassifiedPosted Feb 27, 2026·Initiated Nov 14, 2025

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Root cause: Device Design

Recalling firm: Olympus Corporation of the AmericasType: Lithotriptor, UltrasonicDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.Recall #Z-1478-2026

Open, ClassifiedPosted Feb 27, 2026·Initiated Nov 14, 2025

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Root cause: Device Design

Recalling firm: Olympus Corporation of the AmericasType: Lithotriptor, UltrasonicDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.Recall #Z-1479-2026

Open, ClassifiedPosted Feb 26, 2026·Initiated Jan 21, 2026

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

Reason: Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.

Root cause: Software design

Recalling firm: Agiliti Health - EllisType: Mattress, Air Flotation, Alternating PressureDistribution: US Nationwide distribution.Recall #Z-1472-2026

Open, ClassifiedPosted Feb 26, 2026·Initiated Jan 13, 2026

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Reason: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Root cause: Under Investigation by firm

Recalling firm: Medtronic Perfusion SystemsType: Stabilizer, HeartDistribution: US Nationwide. Global Distribution.Recall #Z-1473-2026

Open, ClassifiedPosted Feb 26, 2026·Initiated Feb 5, 2026

Campy CVA Medium 100/PK, R01272

Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.

Root cause: Under Investigation by firm

Recalling firm: Remel, IncType: Culture Media, Selective And Non-DifferentialDistribution: US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.Recall #Z-1474-2026

Open, ClassifiedPosted Feb 24, 2026·Initiated Jan 15, 2026

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Reason: Knee and Humeral socket implants contain incorrect labeling.

Root cause: Process control

Recalling firm: Encore Medical, LPType: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedDistribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.Recall #Z-1458-2026

Open, ClassifiedPosted Feb 24, 2026·Initiated Jan 15, 2026

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Reason: Knee and Humeral socket implants contain incorrect labeling.

Root cause: Process control

Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.Recall #Z-1459-2026

Open, ClassifiedPosted Feb 24, 2026·Initiated Jan 15, 2026

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Reason: Knee and Humeral socket implants contain incorrect labeling.

Root cause: Process control

Recalling firm: Encore Medical, LPType: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.Recall #Z-1460-2026

Open, ClassifiedPosted Feb 24, 2026·Initiated Jan 14, 2026

PIE Trolley System Model: 2005

Reason: Lack of 510K clearance

Root cause: No Marketing Application

Recalling firm: Edermy LLCType: Colonic Irrigation SystemDistribution: US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.Recall #Z-1461-2026

Open, ClassifiedPosted Feb 24, 2026·Initiated Jan 14, 2026

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Reason: Lack of 510K clearance

Root cause: No Marketing Application

Recalling firm: Edermy LLCType: Colonic Irrigation SystemDistribution: US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.Recall #Z-1462-2026