Recall Watch · FDA Class II
FDA Class II Recall Watch: 14–19 September 2026
Eight selected FDA Class II recalls posted from 14–19 September 2026 highlight transcatheter-device integrity, anesthesia delivery interruption, orthopaedic implant material aging, imaging-data mismatches, diagnostic measurement errors, hemodialysis handling risks, and radiotherapy software limitations. The issue emphasizes both direct clinical consequences and the operational burden of software corrections, inventory control, product returns, and user notifications.
Published Issue FDA posting period 14–19 September 2026
Weekly overview
At a glance
A compact index of this issue. Select an entry to move to its complete record.
| Company/Product | Recall issue | Official action | Quantity | Entry link |
|---|---|---|---|---|
| PI CARDIA LTDPi-Cardia ShortCut | Pi-Cardia recalls ShortCut catheters over positioning-arm weld issue | Pi-Cardia stated that its team would contact affected customers with instructions to identify and return affected inventory. | 529 units | Pi-Cardia recalls ShortCut catheters over positioning-arm weld issue — read full entry |
| Datex-Ohmeda, Inc.Aisys CS2; Aisys CS2 with Et Control | Datex-Ohmeda recalls Aisys CS2 systems over alternate-oxygen transition issue | Users were instructed to complete the specified preoperative checkout and tests before use. | 147 units across two FDA recall records | Datex-Ohmeda recalls Aisys CS2 systems over alternate-oxygen transition issue — read full entry |
| Howmedica Osteonics Corp.Stryker UHMWPE orthopaedic implant components used in hip, knee, shoulder, and elbow systems | Stryker recalls UHMWPE orthopaedic implant components over material aging | Customers were instructed to identify affected product in inventory. | 12,156 US; same FDA Quantity in Commerce value repeated across 12 grouped recall records | Stryker recalls UHMWPE orthopaedic implant components over material aging — read full entry |
| GE HealthcareWorkflow Core Services; Core Services Hub V8 | GE Healthcare recalls imaging workflow systems over patient-data association risk | Customers were instructed not to begin new inbound DICOM migration projects without contacting GE Healthcare. | 419 systems across two FDA recall records | GE Healthcare recalls imaging workflow systems over patient-data association risk — read full entry |
| Philips Ultrasound, LLCPhilips EPIQ Elite Diagnostic Ultrasound System with software version 14.0 | Philips recalls EPIQ Elite systems over Doppler sample-location error | Users were instructed not to use the C5-1 Abd Vasc TSP when there is a possibility of a weak PW Doppler signal. | 219 units | Philips recalls EPIQ Elite systems over Doppler sample-location error — read full entry |
| Midmark CorporationIQvitals Zone configurations affected by Linear Deflation Method performance issue | Midmark recalls IQvitals Zone configurations over inaccurate blood-pressure readings | Users were instructed to use only the Step Deflation Method for blood-pressure measurement. | 207 units across four FDA recall records | Midmark recalls IQvitals Zone configurations over inaccurate blood-pressure readings — read full entry |
| Fresenius Medical Care Renal Therapies Group, LLCCombiSet Hemodialysis Blood Tubing Set | Fresenius recalls CombiSet blood tubing over connection and handling risk | Customers were instructed to review the device instructions for use. | 1743026 units | Fresenius recalls CombiSet blood tubing over connection and handling risk — read full entry |
| PTW FREIBURGVERIQA RT MonteCarlo 3D v3, S070031.520, software version 3.1.18 | PTW recalls VERIQA over bolus-display limitation in secondary dose calculation | Users uncertain whether a bolus is required were instructed not to use VERIQA RT MonteCarlo 3D as the source for that determination. | 2 | PTW recalls VERIQA over bolus-display limitation in secondary dose calculation — read full entry |
Entry 01
Pi-Cardia recalls ShortCut catheters over positioning-arm weld issue
- Company/Product
- PI CARDIA LTD — Pi-Cardia ShortCut
- Recall issue
- Pi-Cardia recalls ShortCut catheters over positioning-arm weld issue
- Official action
- Pi-Cardia stated that its team would contact affected customers with instructions to identify and return affected inventory.
- Quantity
- 529 units
Entry 02
Datex-Ohmeda recalls Aisys CS2 systems over alternate-oxygen transition issue
- Company/Product
- Datex-Ohmeda, Inc. — Aisys CS2; Aisys CS2 with Et Control
- Recall issue
- Datex-Ohmeda recalls Aisys CS2 systems over alternate-oxygen transition issue
- Official action
- Users were instructed to complete the specified preoperative checkout and tests before use.
- Quantity
- 147 units across two FDA recall records
Entry 03
Stryker recalls UHMWPE orthopaedic implant components over material aging
- Company/Product
- Howmedica Osteonics Corp. — Stryker UHMWPE orthopaedic implant components used in hip, knee, shoulder, and elbow systems
- Recall issue
- Stryker recalls UHMWPE orthopaedic implant components over material aging
- Official action
- Customers were instructed to identify affected product in inventory.
- Quantity
- 12,156 US; same FDA Quantity in Commerce value repeated across 12 grouped recall records
Entry 04
GE Healthcare recalls imaging workflow systems over patient-data association risk
- Company/Product
- GE Healthcare — Workflow Core Services; Core Services Hub V8
- Recall issue
- GE Healthcare recalls imaging workflow systems over patient-data association risk
- Official action
- Customers were instructed not to begin new inbound DICOM migration projects without contacting GE Healthcare.
- Quantity
- 419 systems across two FDA recall records
Entry 05
Philips recalls EPIQ Elite systems over Doppler sample-location error
- Company/Product
- Philips Ultrasound, LLC — Philips EPIQ Elite Diagnostic Ultrasound System with software version 14.0
- Recall issue
- Philips recalls EPIQ Elite systems over Doppler sample-location error
- Official action
- Users were instructed not to use the C5-1 Abd Vasc TSP when there is a possibility of a weak PW Doppler signal.
- Quantity
- 219 units
Entry 06
Midmark recalls IQvitals Zone configurations over inaccurate blood-pressure readings
- Company/Product
- Midmark Corporation — IQvitals Zone configurations affected by Linear Deflation Method performance issue
- Recall issue
- Midmark recalls IQvitals Zone configurations over inaccurate blood-pressure readings
- Official action
- Users were instructed to use only the Step Deflation Method for blood-pressure measurement.
- Quantity
- 207 units across four FDA recall records
Entry 07
Fresenius recalls CombiSet blood tubing over connection and handling risk
- Company/Product
- Fresenius Medical Care Renal Therapies Group, LLC — CombiSet Hemodialysis Blood Tubing Set
- Recall issue
- Fresenius recalls CombiSet blood tubing over connection and handling risk
- Official action
- Customers were instructed to review the device instructions for use.
- Quantity
- 1743026 units
Entry 08
PTW recalls VERIQA over bolus-display limitation in secondary dose calculation
- Company/Product
- PTW FREIBURG — VERIQA RT MonteCarlo 3D v3, S070031.520, software version 3.1.18
- Recall issue
- PTW recalls VERIQA over bolus-display limitation in secondary dose calculation
- Official action
- Users uncertain whether a bolus is required were instructed not to use VERIQA RT MonteCarlo 3D as the source for that determination.
- Quantity
- 2
Fully expanded
This week’s entries
Official recall facts and actions are separated from MedTech Current significance analysis.
Pi-Cardia recalls ShortCut catheters over positioning-arm weld issue
Pi-Cardia ShortCut
- Status
- Open, Classified
- Recalling firm
- PI CARDIA LTD
- Manufacturer
- PI CARDIA LTD
- Event ID
- 99664
- Recall number
- Z-3213-2026
- FDA posting date
- Recall initiated
- Quantity
- 529 units
- Distribution
- U.S. distribution in UT, KS, CA, MA, PA, NH, DE, and NY.
Official recall information
What happened
FDA classified Pi-Cardia's ShortCut recall as Class II after the firm identified a weld issue that may allow the catheter's positioning arm to detach. ShortCut is used during transcatheter heart-valve procedures to facilitate leaflet modification. FDA lists 529 units in commerce across eight U.S. states. The firm instructed affected customers to identify and return impacted inventory.
MedTech Current analysis
Why it matters
A structural failure involving a catheter component used during a transcatheter valve procedure can create immediate procedural disruption and retrieval concerns. The event is also relevant to cardiovascular-device manufacturers because a localized weld-control problem can trigger inventory identification and return activity across multiple clinical sites.
Official recall information
Official actions
According to the FDA recall record:
- Pi-Cardia stated that its team would contact affected customers with instructions to identify and return affected inventory.
- Customers were directed to contact their Pi-Cardia representative with questions regarding the field action.
- The firm stated that additional updates would be provided as necessary.
Datex-Ohmeda recalls Aisys CS2 systems over alternate-oxygen transition issue
Aisys CS2; Aisys CS2 with Et Control
- Status
- Open, Classified
- Recalling firm
- Datex-Ohmeda, Inc.
- Manufacturer
- Datex-Ohmeda, Inc.
- Event ID
- 99649
- Recall number
- Z-3190-2026, Z-3191-2026
- FDA posting date
- Recall initiated
- Quantity
- 147 units across two FDA recall records
- Distribution
- Worldwide - US Nationwide distribution.
Official recall information
What happened
FDA posted two Class II records for Aisys CS2 anesthesia systems after certain electronic gas-mixer assemblies were found capable of automatically transitioning to Alternate O2 control. The change delivers 100% oxygen and alarms, but anesthetic-agent delivery is interrupted until clinicians intervene. The grouped records cover Aisys CS2 and Aisys CS2 with Et Control, totaling 147 units in commerce.
MedTech Current analysis
Why it matters
An unexpected transition that interrupts anesthetic-agent delivery can demand immediate clinician recognition and response during anesthesia. The event is significant to hospitals because the correction combines interim operating instructions with inspection of affected service-stock components, while manufacturers must address a nonconforming component in an installed system population.
Official recall information
Official actions
According to the FDA recall records:
- Users were instructed to complete the specified preoperative checkout and tests before use.
- If Alternate O2 control occurs, clinicians were instructed to adjust oxygen flow and use the available guidance for anesthetic delivery.
- If anesthetic-agent delivery is unavailable, users were instructed to supplement or transition to intravenous anesthetics as clinically appropriate.
- Affected service-stock gas-mixer assemblies were to be inspected and disposed of, and GE stated that affected systems would be corrected at no cost.
Stryker recalls UHMWPE orthopaedic implant components over material aging
Stryker UHMWPE orthopaedic implant components used in hip, knee, shoulder, and elbow systems
- Status
- Open, Classified
- Recalling firm
- Howmedica Osteonics Corp.
- Manufacturer
- Howmedica Osteonics Corp.
- Event ID
- 99558
- Recall number
- Z-3195-2026, Z-3196-2026, Z-3197-2026, Z-3198-2026, Z-3199-2026, Z-3200-2026, Z-3201-2026, Z-3202-2026, Z-3203-2026, Z-3204-2026, Z-3205-2026, Z-3206-2026
- FDA posting date
- Recall initiated
- Quantity
- 12,156 US; same FDA Quantity in Commerce value repeated across 12 grouped recall records
- Distribution
- Worldwide distribution including US Nationwide, Canada, Latin America, Europe, Asia Pacific, and South Africa.
Official recall information
What happened
FDA posted 12 Class II records under event 99558 for Stryker orthopaedic implant components made with UHMWPE raw material aged more than five years. The firm identified potential elevated oxidation that may increase wear and contribute to wear debris, material fragments, or device fracture or dissociation. FDA repeats the same Quantity in Commerce value, 12,156 US, across the grouped records, so it is not summed.
MedTech Current analysis
Why it matters
The affected products are implanted orthopaedic components, and the FDA record links increased material oxidation to wear-related outcomes that may include pain, inflammation, and revision surgery. For manufacturers, the event also illustrates how raw-material aging controls and process-change governance can propagate across numerous implant configurations and product families.
Official recall information
Official actions
According to the FDA recall records:
- Customers were instructed to identify affected product in inventory.
- Affected product was to be quarantined and use discontinued.
- Customers were instructed to return affected product to Stryker.
GE Healthcare recalls imaging workflow systems over patient-data association risk
Workflow Core Services; Core Services Hub V8
- Status
- Open, Classified
- Recalling firm
- GE Healthcare
- Manufacturer
- GE Healthcare
- Event ID
- 99661
- Recall number
- Z-3170-2026, Z-3171-2026
- FDA posting date
- Recall initiated
- Quantity
- 419 systems across two FDA recall records
- Distribution
- Worldwide - US Nationwide distribution.
Official recall information
What happened
FDA posted two Class II records for GE Healthcare Workflow Core Services and Core Services Hub V8 after identifying circumstances in which historical imaging data migrated from a legacy system may become associated with the wrong patient. Studies or images could then appear under an incorrect patient record, creating potential for misdiagnosis or delayed diagnosis. The grouped records total 419 systems worldwide.
MedTech Current analysis
Why it matters
Incorrect patient association is a data-integrity failure with direct diagnostic implications even when the underlying images themselves are unchanged. The recall is also operationally significant because healthcare organizations may need to preserve legacy systems, pause new DICOM migration work, and verify migrated studies against patient identifiers while awaiting correction.
Official recall information
Official actions
According to the FDA recall records:
- Customers were instructed not to begin new inbound DICOM migration projects without contacting GE Healthcare.
- Users were instructed to verify that studies and images are associated with the correct patient using available identifiers and clinical context.
- Customers were instructed to maintain prior source systems or migration servers until GE provides further correction guidance.
- Facilities were asked to circulate the notice and return the acknowledgement response.
Philips recalls EPIQ Elite systems over Doppler sample-location error
Philips EPIQ Elite Diagnostic Ultrasound System with software version 14.0
- Status
- Open, Classified
- Recalling firm
- Philips Ultrasound, LLC
- Manufacturer
- Philips Ultrasound, LLC
- Event ID
- 99706
- Recall number
- Z-3249-2026
- FDA posting date
- Recall initiated
- Quantity
- 219 units
- Distribution
- Worldwide distribution including US Nationwide.
Official recall information
What happened
FDA classified Philips EPIQ Elite systems running software version 14.0 as Class II because the displayed Doppler sample may appear shallower than the actual measurement location. The discrepancy can produce inaccurate blood-flow velocity measurements and may contribute to misdiagnosis. FDA lists 219 units in commerce, with distribution across the United States and multiple international markets.
MedTech Current analysis
Why it matters
Doppler measurements can influence vascular and hemodynamic assessment, so a mismatch between displayed and actual sample location has direct diagnostic relevance. The correction also illustrates how a software-design change can alter measurement interpretation while the device remains usable under specific interim restrictions communicated to clinical users.
Official recall information
Official actions
According to the FDA recall record:
- Users were instructed not to use the C5-1 Abd Vasc TSP when there is a possibility of a weak PW Doppler signal.
- Users were instructed to use another appropriate TSP for affected examinations.
- Philips stated that other uses could continue according to the device instructions for use.
- Facilities were asked to circulate and post the notice as appropriate and return the customer response form within 30 days.
Midmark recalls IQvitals Zone configurations over inaccurate blood-pressure readings
IQvitals Zone configurations affected by Linear Deflation Method performance issue
- Status
- Open, Classified
- Recalling firm
- Midmark Corporation
- Manufacturer
- Midmark Corporation
- Event ID
- 99641
- Recall number
- Z-3217-2026, Z-3218-2026, Z-3219-2026, Z-3220-2026
- FDA posting date
- Recall initiated
- Quantity
- 207 units across four FDA recall records
- Distribution
- US Nationwide distribution.
Official recall information
What happened
FDA posted four Class II records for Midmark IQvitals Zone configurations because a performance issue may produce inaccurate blood-pressure readings when the Linear Deflation Method is used. The records share the same event and corrective action, so they are grouped here as one editorial event. FDA lists 1, 153, 20, and 33 units respectively, totaling 207 units in commerce.
MedTech Current analysis
Why it matters
Inaccurate blood-pressure measurements can affect clinical assessment and treatment decisions, especially when the error is not obvious to the user. The field action is operationally important because facilities must verify the measurement method on affected devices and temporarily standardize use around the Step Deflation setting until the product correction is available.
Official recall information
Official actions
According to the FDA recall records:
- Users were instructed to use only the Step Deflation Method for blood-pressure measurement.
- Users were instructed not to use the Linear Deflation Method and to verify that Step Deflation is selected.
- Facilities were asked to inform affected users and complete and return the response form.
- Midmark stated that a product correction would be provided.
Fresenius recalls CombiSet blood tubing over connection and handling risk
CombiSet Hemodialysis Blood Tubing Set
- Status
- Open, Classified
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Event ID
- 99700
- Recall number
- Z-3225-2026
- FDA posting date
- Recall initiated
- Quantity
- 1743026 units
- Distribution
- Domestic: Nationwide Distribution.
Official recall information
What happened
FDA classified the CombiSet Hemodialysis Blood Tubing Set action as Class II and states that the communication recommends renewed attention to the instructions for use and treatment-preparation steps. The record identifies potential consequences including blood loss, treatment delay, and air entering the system if connections are not properly secured. FDA lists 1743026 units in commerce with nationwide U.S. distribution.
MedTech Current analysis
Why it matters
Hemodialysis blood tubing is part of an extracorporeal blood circuit, so connection integrity and preparation steps have direct clinical and workflow importance. The event is notable because the field action focuses on reinforcing correct use rather than removing product, placing much of the immediate burden on training, setup verification, and clinical practice.
Official recall information
Official actions
According to the FDA recall record:
- Customers were instructed to review the device instructions for use.
- Users were instructed to ensure that all treatment-preparation and handling steps are performed as directed.
- The notice emphasizes ensuring that transducer-protector and female-luer connections are finger tight to maintain a closed system.
PTW recalls VERIQA over bolus-display limitation in secondary dose calculation
VERIQA RT MonteCarlo 3D v3, S070031.520, software version 3.1.18
- Status
- Open, Classified
- Recalling firm
- PTW FREIBURG
- Manufacturer
- PTW FREIBURG
- Event ID
- 99720
- Recall number
- Z-3174-2026
- FDA posting date
- Recall initiated
- Quantity
- 2
- Distribution
- Worldwide distribution including the U.S. states of GA and NY and multiple international markets.
Official recall information
What happened
FDA classified PTW's VERIQA RT MonteCarlo 3D v3 recall as Class II because bolus material included in a treatment plan is considered in secondary dose calculation but is not clearly displayed in the software. A user could therefore omit the bolus during treatment and deliver dose to the wrong tissue depth. FDA reports a Quantity in Commerce of 2 without specifying a unit.
MedTech Current analysis
Why it matters
The issue affects radiotherapy dose-checking software and can create a mismatch between calculated and delivered treatment setup if the bolus requirement is missed. Although the quantity is small, the consequence is clinically meaningful because the limitation concerns delivered dose depth.
Official recall information
Official actions
According to the FDA recall record:
- Users uncertain whether a bolus is required were instructed not to use VERIQA RT MonteCarlo 3D as the source for that determination.
- Users were instructed to rely on the treatment-planning system and patient record for bolus requirements.
- The firm stated that VERIQA should not influence the clinical workflow or treatment plan for this determination.
- PTW stated that the issue would be corrected in a future software release and asked recipients to forward the notice as appropriate.
Entries were selected by FDA Recall Posting Date from individual FDA recall database records; each retained FDA record URL is preserved for traceability.