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

5551–5575 of 40007

HighFDA (Devices)·Z-0134-2025·2024-10-30
Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error
Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.
Product
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0184-2025·2024-10-30
Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect
Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0177-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Sterility Risk
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2025·2024-10-30
Baxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk
Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.
Product
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0195-2025·2024-10-30
Medex TranStar Pressure Transducer Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.
Product
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0169-2025·2024-10-30
Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2025·2024-10-30
Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect
Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.
Product
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0191-2025·2024-10-30
Smiths Medical medex TranStar Pressure Monitoring Kits Recalled for Manufacturing Defect
Smiths Medical is recalling 5,880 medex TranStar pressure monitoring kits worldwide due to a manufacturing defect that may cause inaccurate readings, monitoring interruption, or inability to zero the device.
Product
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0205-2025·2024-10-30
Smiths Medical SurgiVet pressure transducer recalled for monitoring failures
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
Product
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0213-2025·2024-10-30
Baxter Operating Table TruSystem 7000 recalled for electrical hazard
Baxter is recalling 1,077 TruSystem 7000 operating tables worldwide due to electrical short-circuits and smoke emissions in battery connectors reported by customers.
Product
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0135-2025·2024-10-30
Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation
Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.
Product
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Sterility Compromise
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2025·2024-10-30
Medline Procedure Kits Recalled for Non-Sterile Product Risk
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0226-2025·2024-10-30
Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure
Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.
Product
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2025·2024-10-30
Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits
Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0188-2025·2024-10-30
Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects
Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.
Product
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0224-2025·2024-10-30
Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.
Product
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2025·2024-10-30
Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
Product
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0077-2025·2024-10-30
Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk
Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2025·2024-10-30
Internal Defibrillation Paddles Recalled for Cracks and Separation
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
Product
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0015-2025·2024-10-30
CADD Medication Cassette Reservoir recalled for weakened weld joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.
Product
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0194-2025·2024-10-30
Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.
Product
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0215-2025·2024-10-30
Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Hazard
Baxter Healthcare recalled 24 units of its TruSystem 7000 operating table worldwide due to battery and connector electrical short-circuits and smoke emission.
Product
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0159-2025·2024-10-30
Medline dental pack may contain non-sterile product due to packaging defect
Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.
Product
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0154-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
Category
Medical Device
Distribution
Distributed nationwide

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5551–5575 of 40007