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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

3776–3800 of 39824

HighFDA (Devices)·Z-1906-2025·2025-06-11
Dexcom G7 iOS App version 2.7.0 stops updating glucose readings
Dexcom G7 iOS App version 2.7.0 can enter a state where glucose readings freeze and alerts do not trigger, risking missed detection of dangerously high or low blood sugar. Other connected devices like Apple Watch and insulin pumps continue to receive glucose data directly from the transmitter.
Product
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1887-2025·2025-06-11
Palindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.
Product
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1899-2025·2025-06-11
Signature Laparoscopic Atraumatic Grasper Instrument Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Atraumatic Grasper instruments (Model 5864000) due to incomplete insulation on the shaft that leaves an exposed area near the rotator wheel, posing an electrical safety risk during surgical use.
Product
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2025·2025-06-11
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack recalled
Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.
Product
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1898-2025·2025-06-11
Signature Laparoscopic Alligator Grasper Instrument Recall Safety Issue
Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated area near the rotator wheel.
Product
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1891-2025·2025-06-11
FoundationOne Companion Diagnostic F1CDx Incorrect Claim Display
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.
Product
FoundationOne Companion Diagnostic (F1CDx)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1892-2025·2025-06-11
BX2 Needle Guide may develop transducer cover breach during attachment
Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.
Product
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1913-2025·2025-06-11
DxI 9000 Access Immunoassay Analyzer Software Update Error Codes
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1909-2025·2025-06-11
Pre-filled Water Syringe recalled for improper use contamination
Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.
Product
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1907-2025·2025-06-11
Beckman Coulter Sample Probe Manufacturing Defect Recall
Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.
Product
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2025·2025-06-11
MIRA Surgical System software update recall for motion display issue
Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.
Product
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1878-2025·2025-06-11
Lazervida 10W Diode Laser Engraver Does Not Meet Federal Safety Standards
Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.
Product
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1890-2025·2025-06-11
FoundationOne Companion Diagnostic contains incorrect negative claims
Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.
Product
FoundationOne Companion Diagnostic (F1CDx)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2025·2025-06-04
ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall
Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1818-2025·2025-06-04
ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem
Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2025·2025-06-04
Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2025·2025-06-04
Abbott Diagnostics Architect Free T4 Calibrator Recall
Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2025·2025-06-04
Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2025·2025-06-04
Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
Product
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1849-2025·2025-06-04
Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion
Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2025·2025-06-04
Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires
Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.
Product
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
Product
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2025·2025-06-04
ELEOS Male-Female Midsection 40MM Orthopedic Component Recall
Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide

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