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

7726–7750 of 13666

HighFDA (Devices)·Z-0518-2024·2023-12-20
Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Product
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2024·2023-12-20
Medical Device Recall: Medline Leg Bag with Undeclared Latex
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Product
Medline Leg bag, REF URO12573
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0517-2024·2023-12-20
Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
Product
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0553-2024·2023-12-20
X-ray system overhead suspension components may fall due to incorrect bolt torque
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2024·2023-12-20
FDA Recalls Medline Leg Bags for Undeclared Latex
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
Product
Medline Leg bag, REF DYND12574
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0544-2024·2023-12-20
FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
Product
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2024·2023-12-20
Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect
Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.
Product
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0546-2024·2023-12-20
Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Product
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2024·2023-12-20
Sterile PVP Medical Solution Recalled for Non-Sterile Contents
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Product
STERILE PVP, REF DYNDA1649
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2024·2023-12-20
GE Definium Tempo X-Ray System Bolts May Loosen and Fall
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2024·2023-12-20
Sterile PVP Solution Kit Recalled for Non-Sterile Contents
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Product
STERILE PVP SLN KIT, REF DYNDM1097
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2024·2023-12-20
Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0550-2024·2023-12-20
Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0551-2024·2023-12-20
Medical imaging software incorrectly displays patient studies to wrong patients
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
Product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2024·2023-12-20
Cardinal Health Stool Transportation System Recalled for Vial Leakage
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
Product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2024·2023-12-20
Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Product
STERILE PVP SOLUTION, REF DYNDA1907
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2024·2023-12-20
Povidone Solution Labeled Sterile Despite Non-Sterile Contents
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Product
STERILE POVIDONE, REF DYNDA2061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2024·2023-12-20
FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Product
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2024·2023-12-20
Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
Product
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2024·2023-12-20
Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2024·2023-12-20
Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0529-2024·2023-12-20
Medline PVP Solution Recalled Due to Mislabeled Sterility
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
Product
PVP SOLUTION SING STRL, REF DYNDA1858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2024·2023-12-20
Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Product
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2024·2023-12-20
Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0519-2024·2023-12-20
Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
Product
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Category
Medical Device
Distribution
Distributed nationwide

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7726–7750 of 13666