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

4726–4750 of 13543

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-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
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-0147-2025·2024-10-30
Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues
Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.
Product
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0206-2025·2024-10-30
Medtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer
Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.
Product
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
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-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-0223-2025·2024-10-30
A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Product
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile product risk
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2025·2024-10-30
Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information
Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.
Product
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0173-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2025·2024-10-30
Smiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty
Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.
Product
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AI
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-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-0148-2025·2024-10-30
Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Product
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2025·2024-10-30
Medline chest tube insertion tray may contain non-sterile equipment due to breached seal
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Product
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2025·2024-10-30
Medex TranStar pressure monitoring sets recalled due to manufacturing defect
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
Product
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0187-2025·2024-10-30
Smiths Medical Arterial Kit recalled for pressure monitoring defect
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
Product
medex Arterial Kit 1/EA, Product Code REF MX7827
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0211-2025·2024-10-30
Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Risk
Baxter Healthcare Corporation is recalling the TruSystem 7000 Operating Table due to battery and connector short-circuits that can emit smoke, creating fire and electrical hazards during surgery.
Product
Baxter Operating Table TruSystem 7000, Product code REF 1841046
Category
Medical Device
Distribution
0 states
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-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-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-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-0014-2025·2024-10-30
CADD Medication Cassette Reservoir weld defect poses leakage risk
Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.
Product
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states

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4726–4750 of 13543