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Patient-Relevant Medical Devices recalls

Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.

Limited official informationPatient-Relevant Medical Devices

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 336...

Due to stain present on the surface of affected foley catheters.

AffectedSilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley C...
RiskDue to stain present on the surface of affected foley catheters.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

AffectedSwan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P; Swan-Ganz Pacing Catheter, Models: D200F7;; plus 1 addition...
RiskCatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lum...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

AffectedTangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
RiskAffected devices exhibited fractures at the distal shaft tip without complete detachment.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-...

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding...

AffectedArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-...
Risk16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

BARD Dynamic Tip Steerable, Product Number 6DYNTP001

Incomplete seals on sterile product

AffectedBARD Dynamic Tip Steerable, Product Number 6DYNTP001;; BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSE...
RiskIncomplete seals on sterile product
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software...

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "repla...

AffectedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numb...
RiskA software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-142...

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

AffectedBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product...
RiskDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pa...

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding o...

AffectedCustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic R...
RiskAffected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rota...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518...

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture;...

AffectedLVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 2...
RiskStent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or inco...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Medline has identified the presence of particulate within the fluid path of the Manifolds.

AffectedMedline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU D...
RiskMedline has identified the presence of particulate within the fluid path of the Manifolds.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A...

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of ord...

AffectedMedtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following dev...
RiskSoftware issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps s...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

AffectedOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
RiskHeart valves were released and distributed before all required testing was complete, so it cannot be confirmed that t...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Product has the potential for false positive results

AffectedQuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
RiskProduct has the potential for false positive results
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

AffectedRevolution CT ES, X-ray Computed Tomography, Model Number 5590000-15; Revolution Ascend, computed tomography, Model N...
RiskGE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health L...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part...

Potential for mislabeled syringe produced by the i.v.STATION device.

AffectedRolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE...
RiskPotential for mislabeled syringe produced by the i.v.STATION device.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-...

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

AffectedSELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS...
RiskComplaints have been received of systems developing loose, missing, or broken internal bolts over time.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the Flu...

Due to nonconforming products being inadvertently distributed.

AffectedThermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to...
RiskDue to nonconforming products being inadvertently distributed.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Contamination to in-vitro diagnostic test may result in false positives.

AffectedBioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
RiskContamination to in-vitro diagnostic test may result in false positives.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Produ...

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

AffectedBrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar...
RiskDue to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP...

Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss,...

AffectedConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mod...
RiskImpacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

AffectedDEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25; DEX Ophthalmic Ti...
RiskField Safety Corrective Action for IFU in DEX Forceps and Scissors.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

AffectedHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.; Halyard CARDIAC CATH PACK SAN23CARDQ...
RiskPotential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-00...

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms s...

AffectedLIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99...
RiskSome defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

AffectedOne Step K in vitro diagnostic test REF: 81A4; Uric Acid in vitro diagnostic test REF: 31H0P; plus 5 additional offic...
RiskThe devices were distributed without required FDA premarket clearance or approval.
ActionNot available

Missing from associated official evidence: action, consumer scope.