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

5576–5600 of 40007

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-0189-2025·2024-10-30
Smiths Medical TranStar Patient Mount Monitoring Kit recalled for pressure measurement defects
Smiths Medical recalls the medex TranStar Patient Mount Monitoring Kit (1,740 units) due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Product
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0219-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
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-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-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-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-0220-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
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-0201-2025·2024-10-30
Blood Sample Pressure Kit Recalled for Monitoring Defects
Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.
Product
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-0149-2025·2024-10-30
Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise
Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
Product
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2025·2024-10-30
Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits
Smiths Medical ASD, Inc. is recalling 900 units of medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0138-2025·2024-10-30
Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.
Product
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2025·2024-10-30
Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming
Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.
Product
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0166-2025·2024-10-30
Medline Medical Procedure Convenience Kits Class II Recall
Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.
Product
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0144-2025·2024-10-30
Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns
Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.
Product
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0207-2025·2024-10-30
Diasol Acid Concentrate Recalled for Labeling Discrepancy
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.
Product
Diasol Acid Concentrate REF G100325-10Dex 100
Category
Medical Device
Distribution
Distributed nationwide

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5576–5600 of 40007