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

5501–5525 of 39968

SevereFDA (Devices)·Z-0078-2025·2024-10-30
Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.
Product
Avance. 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
SevereFDA (Devices)·Z-0074-2025·2024-10-30
Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection
Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.
Product
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are 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 adminis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0082-2025·2024-10-30
Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.
Product
Aisys CS2. 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
SevereFDA (Devices)·Z-0076-2025·2024-10-30
Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk
Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire 7900. 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
SevereFDA (Devices)·Z-0080-2025·2024-10-30
Anesthesia gas machines pose risk of breathing circuit misconnection
Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.
Product
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are 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
SevereFDA (Devices)·Z-0083-2025·2024-10-30
Aisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard
Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.
Product
Aisys CS2 with Et Control. 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
SevereFDA (Devices)·Z-0046-2025·2024-10-30
Life2000 Ventilator May Fail to Alarm on Low Gas Pressure
Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.
Product
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0075-2025·2024-10-30
Aespire 100 anesthesia machine breathing circuit misconnection FDA recall
Datex-Ohmeda Aespire 100 anesthesia machines are recalled due to potential misconnection of breathing circuit limbs to the Auxiliary Common Gas Outlet port, which could impair anesthesia or ventilation delivery.
Product
Aespire 100. 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-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-0161-2025·2024-10-30
Medline medical procedure kits recalled for potential sterility breach
Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
Category
Medical Device
Distribution
Distributed nationwide
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-0168-2025·2024-10-30
Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product
Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.
Product
Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2025·2024-10-30
Shimadzu Trinias Unity Catheterization Table Movement Control Defect
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
Product
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0150-2025·2024-10-30
Medline Centurion Medical Procedure Kits Recalled for Sterility Risk
Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.
Product
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
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-0203-2025·2024-10-30
Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring
Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.
Product
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0013-2025·2024-10-30
CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0133-2025·2024-10-30
Medline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects
Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.
Product
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile;
Category
Medical Device
Distribution
Distributed nationwide
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-0212-2025·2024-10-30
Baxter Operating Table Recalled for Battery Short-Circuit and Smoke Risk
Baxter is recalling its TruSystem 7000 operating table worldwide due to customer reports of battery and connector short-circuits that emitted smoke. All serial numbers are affected.
Product
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0183-2025·2024-10-30
Medex TranStar ICP Pressure Monitoring Device Recalled Due to Manufacturing Defect
Smiths Medical is recalling the medex TranStar Single ICP Set because a manufacturing defect may cause inaccurate pressure monitoring, monitoring interruptions, or inability to zero the device.
Product
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0182-2025·2024-10-30
medex TranStar Pressure Transducer Recall Due to Manufacturing Defect
Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Product
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
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-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-0151-2025·2024-10-30
Centurion OB Tray medical kit recalled due to potential non-sterility
Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
Product
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide

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5501–5525 of 39968