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

5476–5500 of 39844

HighFDA (Devices)·Z-0160-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-0221-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error
Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2025·2024-10-30
Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2025·2024-10-30
Medex TranStar Kids blood sample kit recalled for pressure monitoring failures
Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.
Product
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0012-2025·2024-10-30
CADD Medication Cassette Reservoir recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Category
Medical Device
Distribution
0 states
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-0156-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-0210-2025·2024-10-30
Baxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk
Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.
Product
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0170-2025·2024-10-30
Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
Product
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Product
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
Category
Medical Device
Distribution
Distributed nationwide
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-0146-2025·2024-10-30
Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue
Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.
Product
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Category
Medical Device
Distribution
0 states
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-0176-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2025·2024-10-30
SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption
Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2025·2024-10-30
Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction
The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of monitoring, or inability to zero the device.
Product
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Category
Medical Device
Distribution
0 states
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
HighFDA (Devices)·Z-0196-2025·2024-10-30
medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect
Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.
Product
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

5476–5500 of 39844