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.

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2376–2400 of 13381

HighFDA (Devices)·Z-2499-2025·2025-09-10
Defibrillator servicing inspections not performed; Physio-Control LIFEPAK CR2 recalled
Physio-Control is recalling LIFEPAK CR2 defibrillators due to failure to perform required inspections on serviced units. Affected units were distributed in Colorado and Montana.
Product
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2525-2025·2025-09-10
CADD Medication Cassette Reservoir Recall Due to Weakened Welds
ICU Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened bag welds that may cause medication leakage. No injuries have been reported.
Product
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2494-2025·2025-09-10
RayStation Radiation Therapy Software Faces Unique Patient Data Identifier Issue
RayStation radiation therapy treatment planning software may not guarantee unique identifiers for patient images, potentially leading to data mix-up during treatment planning.
Product
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2502-2025·2025-09-10
Philips Azurion and Allura imaging systems may shut down during power loss
Philips Azurion and Allura medical imaging systems configured with certain 1-Phase power supplies may shut down or fail to start if power is lost. The recall affects approximately 1,861 units distributed worldwide.
Product
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2508-2025·2025-09-10
MediHoney Adhesive Hydrogel Dressing Recalled for Sterile Barrier Packaging Failure
Integra LifeSciences is recalling MediHoney Adhesive Hydrogel Dressing due to packaging failures that could breach the sterile barrier. The recall affects 994 units distributed in the US and internationally.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2025·2025-09-10
RayStation radiation therapy software versions have non-unique DICOM identifiers
RayStation radiation therapy software versions 10.1.0.613 and 10.1.1.54 may have non-unique DICOM identifiers affecting treatment planning data integrity. The recall covers 3 units distributed across the US and internationally.
Product
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2518-2025·2025-09-10
Pressure Sensor Error in Merge Hemo Cardiac Monitoring System Recall
The Merge Hemo hemodynamics monitoring system is recalled due to a pressure sensor defect in its integrated Schiller ARGUS component, which triggers error messages during blood pressure measurements in high-pressure ranges. Eighty-four units distributed nationwide are affected.
Product
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2486-2025·2025-09-10
RefleXion X1 radiation therapy system software configuration error causes excessive dose fractionation
RefleXion X1 Model RXM1000 radiation therapy systems may deliver excessive radiation due to a software configuration error that allows more than two fractions in 12 hours, potentially causing toxicity.
Product
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2025·2025-09-10
RayStation Radiation Therapy Software Recalled for Data Integrity Issue
RayStation radiation therapy planning software by RaySearch Laboratories AB has been recalled due to a data integrity issue where DICOM instance identifiers are not guaranteed to be unique, potentially affecting treatment plan accuracy.
Product
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2507-2025·2025-09-10
MediHoney HCS Sheet Wound Dressing Recalled for Packaging Sterile Barrier Failures
Integra LifeSciences is recalling MediHoney HCS Sheet Dressing due to packaging failures that could compromise the sterile barrier and allow product contamination. The recall affects 3,583 units distributed worldwide.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2498-2025·2025-09-10
LIFEPAK 1000 defibrillators recalled for missed required post-service inspections
Physio-Control is recalling three LIFEPAK 1000 defibrillators due to required inspections not being performed after servicing. The affected units were distributed in Colorado and Montana.
Product
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2510-2025·2025-09-10
Wound dressing recall due to potential sterile barrier packaging failures
Integra's MediHoney Hydrogel Adhesive Sheet dressings may have packaging failures compromising sterility. Affected units are being recalled worldwide.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2506-2025·2025-09-10
Medical device wound dressing recalled due to packaging failures compromising sterile barrier
Integra LifeSciences is recalling MediHoney wound dressing tubes due to packaging failures that could compromise the sterile barrier. The recall affects approximately 141,620 units distributed nationwide and internationally.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 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 envir
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2509-2025·2025-09-10
MediHoney Hydrogel wound dressings recalled for packaging failures
Integra is recalling MediHoney Hydrogel non-adhesive dressings due to packaging failures that could breach the sterile barrier. Approximately 5374 affected units were distributed worldwide.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2511-2025·2025-09-10
Surgical Wound Dressing Recalled Due to Packaging Defect
Integra LifeSciences is recalling MediHoney HCS Surgical Adhesive Sheets due to packaging failures that could compromise the product's sterile barrier.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2487-2025·2025-09-10
RayStation Radiation Therapy Software Contains Non-Unique Patient Identifier Codes
RayStation radiation therapy planning software may use non-unique identifiers for patient imaging data, potentially causing patient identification errors during treatment planning. Affected versions are 7.0.0.19, 8.0.0.61, and 8.0.1.10.
Product
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning Sys
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2501-2025·2025-09-10
Blood Uric Acid Monitoring System Recalled for Lack of FDA Premarket Approval
Visgeneer, Inc. is recalling Blood Uric Acid Monitoring System kits distributed without FDA premarket approval in the U.S. and Canada.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2504-2025·2025-09-10
Philips Allura Xper X-Ray Systems Recalled for Potentially Missing Component
Philips is recalling 192 Allura Xper Series interventional fluoroscopic X-ray systems because an air baffle component may be missing from some units. The systems have been distributed in multiple U.S. states and internationally.
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. 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. 4. All
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2524-2025·2025-09-10
Smiths Medical CADD Medication Cassette Reservoirs Recalled for Potential Medication Leakage
ICU Medical is recalling Smiths Medical CADD 100mL medication cassette reservoirs due to weakened bag welds that may cause medication leakage. The recall involves 289,098 units distributed worldwide.
Product
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2515-2025·2025-09-10
Platelia Toxo IgM immunoassay kit recalled for risk of false positives
Bio-Rad is recalling Platelia Toxo IgM immunoassay kits due to a risk of false positive results that could lead to unnecessary medical treatment.
Product
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2514-2025·2025-09-10
Dental Implant Titanium Base Recalled for Manufacturing Misalignment
Preat Corp is recalling NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base units due to a manufacturing defect causing 180-degree misalignment. The error prevents dental crowns from fitting properly onto the abutment, resulting in restoration delays.
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2500-2025·2025-09-10
Blood Uric Acid Monitoring System recalled for lacking FDA premarket clearance
Visgeneer's Blood Uric Acid Monitoring System kits were distributed without FDA premarket clearance. Approximately 2,240 units were distributed in California, Michigan, and Canada.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2517-2025·2025-09-10
FloPatch FP120 Flowmeter Patch Recalled for Incorrect Expiry Date on Packaging
Flosonics Medical is recalling the FloPatch FP120 flowmeter patch due to an incorrect expiry date printed on the outer shipping packaging. The package label reads 2025-06-20 instead of the correct 2026-06-20.
Product
FloPatch FP120, REF: FP120-FOT01-005
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2460-2025·2025-09-03
Medline ReNewal Reprocessed Electrophysiology Catheters May Contain Residual Particulates
Medline ReNewal reprocessed electrophysiology catheters may contain small residual particulates. The catheters were distributed nationwide to healthcare facilities.
Product
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2343-2025·2025-09-03
Insulin Pumps Recalled for Speaker Malfunction and Inoperability Risk
Tandem Diabetes insulin pumps may malfunction due to defective speakers, preventing audible alerts and stopping insulin delivery. This could cause dangerous blood sugar spikes requiring hospitalization.
Product
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
Category
Medical Device
Distribution
Distributed nationwide

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2376–2400 of 13381