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

6526–6550 of 27393

HighFDA (Devices)·Z-0606-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0609-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0610-2024·2023-12-27
LITe Decompression Snake Arm cannot attach due to incorrect clamp component
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
Product
LITe Decompression Snake Arm, REF 48080230
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-0548-2024·2023-12-20
CereLink ICP Extension Cable Recalled for Out of Range Readings
Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.
Product
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0505-2024·2023-12-20
Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure
Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.
Product
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0534-2024·2023-12-20
Medline Leg Bags Recalled Due to Undeclared Latex
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Product
Medline Leg bag, REF DYND12578
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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-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-0554-2024·2023-12-20
Sensica Urine Output System displays incorrect timestamps when connected to WiFi
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Product
Sensica Urine Output System, Catalog Number SCCS1002
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
18 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-0530-2024·2023-12-20
Non-sterile Betadine solution labeled and distributed as sterile
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Product
STERILE BETADINE, REF DYNDA1998
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-0522-2024·2023-12-20
SynchroMed Model A10 Infusion Pump Software Display Error
Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.
Product
Medtronic SynchroMed, Model A10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0557-2024·2023-12-20
Olympus tracheal intubation fiberscope recalled due to suction flow specification issue
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
Product
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Category
Medical Device
Distribution
Distributed nationwide
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

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6526–6550 of 27393