Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

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2351–2375 of 13381

SevereFDA (Devices)·Z-2433-2025·2025-09-10
WATCHMAN TruSeal Access System recalled for air embolism risk in cardiac procedures
Boston Scientific is recalling the WATCHMAN TruSeal Access System for risk of air embolism during cardiac procedures. The device increases air ingress risk when procedures lack positive pressure-controlled ventilation, particularly under conscious or deep sedation.
Product
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2426-2025·2025-09-10
WATCHMAN TruSeal Access System recalled for air embolism risk
Boston Scientific is recalling WATCHMAN TruSeal Access System devices worldwide due to increased air embolism risk when procedures are performed without positive pressure-controlled ventilation, particularly in sedated patients.
Product
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2459-2025·2025-09-10
Electrical wheelchair component firmware flaw may cause unintended movement
mo-Vis BVBA is recalling IDM-ARLITE-R electrical wheelchair components due to a firmware defect. Affected units with firmware versions 2.3 and lower may skip the neutral position check on power-up, causing unexpected wheelchair movement.
Product
IDM-ARLITE-R. Electrical wheelchair component.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2434-2025·2025-09-10
Boston Scientific WATCHMAN FXD Cardiac Access System Recalled for Air Embolism Risk
Boston Scientific is recalling the WATCHMAN FXD Curve Access System worldwide. The device carries elevated air embolism risk when used during cardiac procedures without positive pressure-controlled ventilation, particularly in sedated patients.
Product
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2447-2025·2025-09-10
Dexcom G7 and ONE+ CGM apps recalled over missed sensor failure alerts
Dexcom G7 and ONE+ CGM mobile apps fail to alert users of critical sensor failures, which may cause missed detection of dangerous blood sugar events and delayed treatment.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2488-2025·2025-09-10
RayStation Radiation Therapy Software: Non-Unique Medical Image Identifiers
Multiple versions of RayStation, a radiation therapy treatment planning system, are being recalled due to non-unique DICOM identifiers in the RayGateway interface, which could lead to image mix-ups during treatment planning.
Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2025·2025-09-10
Superion Indirect Decompression System spinal implants recalled for device breakage
Boston Scientific recalls Superion Indirect Decompression System spinal implants due to device and instrument breakage affecting performance.
Product
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2491-2025·2025-09-10
RayStation Radiation Therapy Planning System Affected by Non-unique Identifier Issue
RayStation radiation therapy planning software is being recalled because DICOM identifiers are not guaranteed to be unique, potentially affecting data integrity. This FDA Class II recall applies to units distributed across the US and internationally.
Product
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2025·2025-09-10
RayStation Radiation Therapy Planning System DICOM Identifier Collision Risk
RayStation radiation therapy planning software has DICOM identifiers that are not guaranteed to be unique. This could cause patient data attribution errors when interfacing with Accuray's iDMS system.
Product
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2496-2025·2025-09-10
InPen App Software Error May Miss Insulin Dose Reminders
Medtronic is recalling certain InPen App versions due to software errors that could cause missed insulin dose reminders. The app may fail to alert users, potentially delaying diabetes treatment, though no actual incidents have been reported.
Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2527-2025·2025-09-10
Smiths Medical CADD Cassette Reservoirs Recalled for Potential Medication Leakage
Smiths Medical CADD medication cassette reservoirs may leak due to weakened bag welds. The recall involves 15,546 units distributed worldwide.
Product
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2512-2025·2025-09-10
CVS Honey Pad wound dressing recalled due to packaging failures
CVS Honey Pad wound dressings are being recalled due to packaging failures that could compromise the sterile barrier. Approximately 111,492 units were distributed nationwide and internationally.
Product
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2025·2025-09-10
Philips Allura Imaging Systems May Shut Down During Power Loss Events
Philips Allura medical imaging systems configured with certain power supplies may shut down or fail to start if power is lost, potentially disrupting patient care. Affected facilities should contact Philips to verify configuration and arrange remediation.
Product
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2025·2025-09-10
TOPS Inserter surgical instrument recalled for missing pins
PREMIA SPINE LTD is recalling TOPS Inserter instruments (Model 82889) due to potential missing pins at the tip. The recall affects 30 units distributed in Connecticut.
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2495-2025·2025-09-10
RayStation Radiation Therapy Software DICOM Instance Identifier Uniqueness Issue
RayStation radiation therapy planning software versions 2023B, 2024A, and 2024A SP3 have a data integrity issue where DICOM instance identifiers may not be unique, potentially mixing patient imaging data. Contact RaySearch Laboratories for guidance.
Product
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2025·2025-09-10
Surgical Drape Packs With Open Seals May Compromise Sterility
O&M Halyard is recalling 1,316 surgical drape packs (Models 88041-12 and 77165-06) with open seals that may compromise product sterility. Products were distributed nationwide in Georgia, Alabama, Pennsylvania, and Mexico.
Product
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2025·2025-09-10
CADD Medication Cassette Reservoir Recalled for Potential Medication Leakage
ICU Medical is recalling certain CADD medication cassette reservoirs worldwide due to weakened bag welds that could allow medication to leak. No illnesses have been reported.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2519-2025·2025-09-10
Sterile Cover Surgical Device Recalled for Risk of Elastic Band Detachment
Lumicell's sterile surgical covers are being recalled because elastic bands may detach or fracture during surgery, potentially leaving foreign bodies in the surgical site and causing infection. The recall affects 200 units in CA, FL, MA, NC, and TX.
Product
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2025·2025-09-10
Medshape Universal Joints Recalled for Pin Dislodgement and Frame Instability
Medshape Universal Joints (REF: DNE-9000-UJ) used in bone external fixation are recalled because securing pins can become dislodged, causing frame instability that may delay surgery or require device revision.
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2492-2025·2025-09-10
Radiation Therapy Planning System Affected by Non-Unique Data Identifiers
RAYSEARCH's RayStation treatment planning software has a defect where medical imaging data identifiers are not guaranteed to be unique, potentially causing incorrect patient data retrieval. This is an FDA Class II recall affecting facilities in 18 US states and multiple countries.
Product
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2505-2025·2025-09-10
Medical wound dressing recalled for sterile packaging barrier failures
Integra LifeSciences is recalling MediHoney Paste, a medical wound dressing, due to packaging failures that could compromise the sterile barrier. The recall affects 15,441 units distributed worldwide.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2526-2025·2025-09-10
Smiths Medical CADD Medication Cassette Reservoirs Recalled for Weakened Welds
Smiths Medical CADD medication cassette reservoirs are being recalled due to weakened welds that could allow medication to leak. Approximately 987,911 units worldwide are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2497-2025·2025-09-10
LIFEPAK 15 defibrillators recalled for missing post-service quality inspections
Physio-Control is recalling LIFEPAK 15 defibrillators because required inspections were not performed after servicing. Four units distributed in Colorado and Montana are affected.
Product
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2521-2025·2025-09-10
Medical device assay recalled for incorrect test results and therapy recommendations
The MI Cancer Seek assay is being recalled because it provided incorrect test results that led to incorrect drug therapy recommendations for cancer patients.
Product
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients wi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2025·2025-09-10
CADD Medication Cassette Reservoirs recalled for potential medication leakage
ICU Medical is recalling approximately 265,500 CADD 50mL and 100mL Medication Cassette Reservoirs worldwide due to weakened bag welds that could cause medication leakage during use.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Category
Medical Device
Distribution
0 states

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