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

4751–4775 of 13543

HighFDA (Devices)·Z-0179-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
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-0017-2025·2024-10-30
Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
Product
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
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-0217-2025·2024-10-30
Baxter Operating Table TruSystem 7000 U14 Recalled for Battery Short-Circuit Risk
Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.
Product
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0145-2025·2024-10-30
Smiths Medical Y-Piece Airway Connector Recalled Due to Sterile Packaging Integrity Uncertainty
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Product
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
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-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-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-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
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-0079-2025·2024-10-30
Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet
Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.
Product
Amingo. OUS only.
Category
Medical Device
Distribution
Distributed nationwide
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-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-0216-2025·2024-10-30
Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards
Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.
Product
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0162-2025·2024-10-30
Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging
Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.
Product
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2025·2024-10-30
Medline catheter procedure kits recalled for potential sterility compromise
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Product
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
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-0157-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging defect
Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
Category
Medical Device
Distribution
Distributed nationwide
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-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-0172-2025·2024-10-30
Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Product
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2025·2024-10-30
Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2025·2024-10-30
Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Product
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2025·2024-10-30
medex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect
Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.
Product
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Category
Medical Device
Distribution
0 states

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4751–4775 of 13543