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 27364

HighFDA (Devices)·Z-0605-2024·2023-12-27
Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2024·2023-12-27
Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Product
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0588-2024·2023-12-27
Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Product
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0572-2024·2023-12-27
Injection needles and cannulas recalled for cleaning process efficacy issues
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
Product
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0601-2024·2023-12-27
Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Product
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Category
Medical Device
Distribution
Distributed nationwide
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-0583-2024·2023-12-27
Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
Product
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0579-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for vacuum loss in bags
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Product
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0578-2024·2023-12-27
Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
Product
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0571-2024·2023-12-27
Injection Needle Recall Due to Cleaning Process Concerns
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.
Product
Injection Needle, REF: 25207
Category
Medical Device
Distribution
38 states
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
HighFDA (Devices)·Z-0558-2024·2023-12-27
Philips Allura Medical Imaging Systems Ceiling Mount May Fall
Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.
Product
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2024·2023-12-27
Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0607-2024·2023-12-27
RAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias
Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0608-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2024·2023-12-27
Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Product
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0573-2024·2023-12-27
Injection Needles Recalled for Inadequate Manual Cleaning Process
Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.
Product
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0582-2024·2023-12-27
Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
Product
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Category
Medical Device
Distribution
16 states
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-0587-2024·2023-12-27
Exactech Vantage Ankle System Recalled Due to Vacuum Loss
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Product
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Category
Medical Device
Distribution
16 states
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
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
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-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

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6526–6550 of 27364