Open, ClassifiedPosted Oct 23, 2025·Initiated Sep 12, 2025
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0303-2026
Open, ClassifiedPosted Oct 22, 2025·Initiated Sep 30, 2025
Brand Name: Hemodialysis Bloodlines
Product Name: STREAMLINE BLOODLINE SET FOR DIALOG
Model/Catalog Number: SL-2010M2096
Software Version: N/A
Product Description: STREAMLINE BLOODLINE SET FOR DIALOG
Component: N/A
Reason: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Domestic: US Nationwide Distribution.Recall #Z-0070-2026 Open, ClassifiedPosted Oct 22, 2025·Initiated Aug 22, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Reason: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Root cause: Device Design
Recalling firm: GE Medical Systems, LLCType: ElectrocardiographDistribution: Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.Recall #Z-0231-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 5, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
Reason: Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
Root cause: Software design
Recalling firm: Wipro GE Healthcare Private Ltd.Type: Display, Cathode-Ray Tube, MedicalDistribution: Worldwide distribution.Recall #Z-0213-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 5, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
Reason: Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
Root cause: Software design
Recalling firm: Wipro GE Healthcare Private Ltd.Type: Display, Cathode-Ray Tube, MedicalDistribution: Worldwide distribution.Recall #Z-0214-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 19, 2025
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, CortisolDistribution: Worldwide - US Nationwide distribution.Recall #Z-0215-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 19, 2025
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, Thyroid-Stimulating HormoneDistribution: Worldwide - US Nationwide distribution.Recall #Z-0216-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 530
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0217-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 550
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0218-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 760
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0219-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 780
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0220-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT ATLAS
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0221-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uEXPLORER
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0222-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 550
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0223-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 780
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0224-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 12, 2025
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI Panorama 35
MD, Rx Only
Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root cause: Other
Recalling firm: UIH Technologies LLCType: System, X-Ray, Tomography, ComputedDistribution: US:
OUS:Recall #Z-0225-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Jul 25, 2025
One Step Sterile Lancet for Single Use (3 sizes):
06949517008861 30g
06949517008854 28g
06949517008847 23g
The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Root cause: Error in labeling
Recalling firm: Home Health US, IncorporatedType: Multiple Use Blood Lancet For Single Patient Use OnlyDistribution: U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA.
O.U.S.: N/ARecall #Z-0226-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 11, 2025
iNSitu Bipolar Hip System, Bipolar head implant
Part ID Description
10-22-0038 Bipolar Head Assembly, Size 38mm
10-22-0040 Bipolar Head Assembly, Size 40mm
10-22-0042 Bipolar Head Assembly, Size 42mm
10-22-0044 Bipolar Head Assembly, Size 44mm
10-22-0046 Bipolar Head Assembly, Size 46mm
10-22-0048 Bipolar Head Assembly, Size 48mm
10-22-0050 Bipolar Head Assembly, Size 50mm
10-22-0052 Bipolar Head Assembly, Size 52mm
10-22-0054 Bipolar Head Assembly, Size 54mm
10-22-0056 Bipolar Head Assembly, Size 56mm
10-22-0058 Bipolar Head Assembly, Size 58mm
10-22-0060 Bipolar Head Assembly, Size 60mm
Reason: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Root cause: Package design/selection
Recalling firm: Theken Companies LLCType: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateDistribution: US Nationwide distribution in the states of NJ, PA, and TX.Recall #Z-0227-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 26, 2025
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System.
Reason: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Root cause: Process control
Recalling firm: Synthes (USA) Products LLCType: Nail, Fixation, BoneDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.Recall #Z-0228-2026
Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 26, 2025
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System.
Reason: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Root cause: Process control
Recalling firm: Synthes (USA) Products LLCType: Nail, Fixation, BoneDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.Recall #Z-0229-2026