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Week of Sep 8, 2025

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Sep 9, 2025device recall319d agoBioPro, Inc. device recall (Cls II)Genbiopro Inc

BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3 — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing

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Sep 9, 2025device recall319d agoNOXBOX LTD device recall (Cls I)LINDE PLC

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Reason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. — Status: Ongoing

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Sep 10, 2025device recall318d agoAbbott device recall (Cls I)

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter — Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. — Status: Ongoing

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Sep 10, 2025device recall318d agoAbbott device recall (Cls I)

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter — Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. — Status: Ongoing

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Sep 10, 2025device recall318d agoAbbott device recall (Cls I)

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter — Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. — Status: Ongoing

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Sep 10, 2025device recall318d agoAbbott device recall (Cls I)

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter — Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. — Status: Ongoing

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Sep 10, 2025device recall318d agoMedline Industries, LP device recall (Cls II)

Medline Adult Anesthesia Set, REF DYNJ39985G — Reason: Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking. — Status: Ongoing

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Sep 10, 2025device recall318d agoAbbott device recall (Cls I)

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter — Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. — Status: Ongoing

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Sep 11, 2025device recall317d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes — Reason: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoCareFusion 303, Inc. device recall (Cls I)

BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock — Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoFerno-Washington Inc device recall (Cls II)

FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES. — Reason: The fastening post hardware could loosen allowing the fastening post to detach from the cot — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

TENACIO Pump without InhibiZone; UPN: 72404420; — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoEthicon Endo-Surgery Inc device recall (Cls II)

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 — Reason: The devices were shipped unsterilized. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoTheken Companies LLC device recall (Cls II)

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. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

TENACIO Pump with InhibiZone; UPN: 72404429; — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoInsulet Corporation device recall (Cls II)INSULET CORP

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. — Reason: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 11, 2025device recall317d agoOlympus Corporation of the Americas device recall (Cls I)

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing

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Sep 12, 2025device recall316d agoMedtronic Perfusion Systems device recall (Cls II)

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. — Status: Ongoing

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Sep 12, 2025device recall316d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Elscint SPX6; 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. — Status: Ongoing

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Sep 12, 2025device recall316d agoNoah Medical Corporation device recall (Cls II)

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure. — Reason: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. — Status: Ongoing

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Sep 12, 2025device recall316d agoUIH Technologies LLC device recall (Cls II)

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. — Status: Ongoing

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Sep 12, 2025device recall316d agoUIH Technologies LLC device recall (Cls II)

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. — Status: Ongoing

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Sep 12, 2025device recall316d agoPhilips North America device recall (Cls II)

Cardiac Workstation 5000; Model Number: 860439; — Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. — Status: Ongoing

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