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

3976–4000 of 13512

HighFDA (Devices)·Z-0997-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2025·2025-01-29
CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2025·2025-01-29
Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2025·2025-01-29
Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2025·2025-01-29
Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps
Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.
Product
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2025·2025-01-29
HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination
O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.
Product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1005-2025·2025-01-29
Medical Analyzer Software May Fail to Alert of Expired Reagent Packs
The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.
Product
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0768-2025·2025-01-29
Bodor P and C series laser cutting machines recalled for non-compliance
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Product
Bodor P and C series laser cutting machines
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2025·2025-01-29
Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1000-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Damaged Probe Tips
Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2025·2025-01-29
CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2025·2025-01-29
BD Pyxis MedStation ES Medication Dispenser Drawer and Door Failure Recall
BD Pyxis MedStation ES medication dispensing units may experience drawer and door failures due to latch failure, cable ribbon damage, or magnet displacement. These failures could delay access to medications in healthcare facilities.
Product
BD Pyxis MedStation ES (Med ES Main), REF 323
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1003-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage
Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2025·2025-01-29
Dressing Change Kits Recalled for Potential Package Sterility Compromise
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2025·2025-01-29
Dressing Change Kit Recalled Due to Package Integrity Concern
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2025·2025-01-29
Stryker neurosurgical device labeling mismatch: wrong instruments shipped
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Product
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2025·2025-01-29
Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Product
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1008-2025·2025-01-29
Repeater Bone Tamp Recalled for Component Incompatibility in Spinal Fusion
Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.
Product
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2025·2025-01-29
Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
Product
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2025·2025-01-29
Randox Lipoprotein (a) assay distributed without required FDA clearance
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1001-2025·2025-01-29
Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking
Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0999-2025·2025-01-29
Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips
Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2025·2025-01-29
BD Pyxis MedStation ES AUX medication dispenser drawer and door failures
The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.
Product
BD Pyxis MedStation ES AUX, REF 324
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0996-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage
Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

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3976–4000 of 13512