Open, ClassifiedPosted Nov 13, 2025·Initiated Oct 6, 2025
3gAllergy Specific IgE Universal Kit;
Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2);
Siemens Material Number (SMN): 10380875;
Catalog Number: L2KUN6;
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.Recall #Z-0492-2026 Open, ClassifiedPosted Nov 13, 2025·Initiated Oct 6, 2025
Food Panel 3 Specific Allergen;
Siemens Material Number (SMN): 10385891;
Catalog Number: FP3L4;
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.Recall #Z-0493-2026 CompletedPosted Nov 13, 2025·Initiated Oct 6, 2025
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Reason: The nasal feeding tube may be occluded
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution in the states of MA, RI, NC, OH.Recall #Z-0494-2026
CompletedPosted Nov 13, 2025·Initiated Oct 6, 2025
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
Reason: The nasal feeding tube may be occluded
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution in the states of MA, RI, NC, OH.Recall #Z-0495-2026
CompletedPosted Nov 13, 2025·Initiated Oct 6, 2025
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
Reason: The nasal feeding tube may be occluded
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution in the states of MA, RI, NC, OH.Recall #Z-0496-2026
CompletedPosted Nov 13, 2025·Initiated Oct 6, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
Reason: The nasal feeding tube may be occluded
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution in the states of MA, RI, NC, OH.Recall #Z-0497-2026
CompletedPosted Nov 13, 2025·Initiated Oct 6, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
Reason: The nasal feeding tube may be occluded
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution in the states of MA, RI, NC, OH.Recall #Z-0498-2026
Open, ClassifiedPosted Nov 13, 2025·Initiated Oct 16, 2025
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M
used with RADspeed, SonialVision and FLUOROspeed Systems
The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and
collimator to position the X-ray tube unit.
This unit is used for radiographic examinations of whole body except mammography
when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray
collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table,
and digital radiography system.
Reason: 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.
Root cause: Device Design
Recalling firm: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONType: Tube Mount, X-Ray, DiagnosticDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten.Recall #Z-0499-2026
Open, ClassifiedPosted Nov 13, 2025·Initiated Oct 21, 2025
VerifyNow PRUTest Platelet Reactivity Test REF 85225
UDI-DI code: 10711234150078
The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Reason: Due to an device without a premarket clearance being incorrectly package and distributed.
Root cause: Under Investigation by firm
Recalling firm: Accriva Diagnostics, Inc.Type: System, Automated Platelet AggregationDistribution: Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.Recall #Z-0500-2026
Open, ClassifiedPosted Nov 12, 2025·Initiated Oct 1, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Root cause: Under Investigation by firm
Recalling firm: Siemens Medical Solutions USA, IncType: System, Nuclear Magnetic Resonance ImagingDistribution: US distribution to California. International distribution to Australia, Germany, Great Britian.Recall #Z-0431-2026
Open, ClassifiedPosted Nov 12, 2025·Initiated Sep 18, 2025
Brand Name: Alinity hq Analyzer
Product Name: Alinity hq Analyzer
Model/Catalog Number: 09P68-01
Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US
Product Description: Alinity hq Analyzer
Component: No
Reason: 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.
Root cause: Software design
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM, URUGUAY, and VIETNAM.Recall #Z-0489-2026 Open, ClassifiedPosted Nov 12, 2025·Initiated Sep 24, 2025
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length
REF: HAR9F,
Reprocessed Device for Single Use, STERILEEO, RX ONLY
Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Single-Use Reprocessed Ultrasonic Surgical InstrumentsDistribution: US Nationwide distribution and OUS (foreign) to country of: Canada.Recall #Z-0490-2026
Open, ClassifiedPosted Nov 10, 2025·Initiated Sep 12, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Oxygenator, Cardiopulmonary BypassDistribution: US States: AZ, CA, TNRecall #Z-0487-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 8, 2025
Brand Name: Lithotriptor, Ultrasonic
Product Name: ShockPulse Lithotripsy Transducer
Model/Catalog Number: SPL-T
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.
Component: ShockPulse Lithotripsy System
Reason: The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Lithotriptor, UltrasonicDistribution: Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.Recall #Z-0452-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 26, 2025
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
Record updated 3/19/26 to include:
CARESCAPE B450 MBA313 2095800-001
CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002
CARESCAPE MONITOR B450 B1 2107633-001
CARESCAPE MONITOR B450-GS (V2.0.8)
2094080-001
Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Root cause: Component change control
Recalling firm: GE Healthcare Finland OyType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0453-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 26, 2025
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
Updated 3/19 to add
CARESCAPE ONE MBZ101
2087075-001
Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Root cause: Component change control
Recalling firm: GE Healthcare Finland OyType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0454-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 26, 2025
B105P, B125P, B105M, B125M, B155M Patient Monitors;
Model nos.
6160000-002
6160000-003
6160000-004
6160000-005
6160000-101
6160000-102
6160000-103
6160000-104
6160000-105
6160001-063
6160001-064
6160001-065
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
3/19/26 updated to add
B105P Patient Monitor
6160001-061
B125P Patient Monitor
6160001-062
B105M-C Patient Monitor
6160002-033
B105M-A Patient Monitor
6160000-113
B155M-A Patient Monitor
6160000-115
B125P-B Patient Monitor
6160002-022
B105M-B Patient Monitor
6160002-023
B125M-B Patient Monitor
6160002-024
B105M-OR Patient Monitor
6160000-143
B105M-OR Patient Monitor
6160000-144
B155M-OR Patient Monitor
6160000-145
Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Root cause: Component change control
Recalling firm: GE Healthcare Finland OyType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0455-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 26, 2025
Portrait VSM
Model nos.
6660000-666
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Root cause: Component change control
Recalling firm: GE Healthcare Finland OyType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0456-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 26, 2025
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS
used with affected patient monitors
Model No 2062895-001
Manufacturer Part Number U80296-1R01, revision S
Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Root cause: Component change control
Recalling firm: GE Healthcare Finland OyType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0457-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 6, 2025
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Root cause: Process control
Recalling firm: Abbott MedicalType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: Worldwide distribution.Recall #Z-0458-2026