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

4426–4450 of 13526

HighFDA (Devices)·Z-0532-2025·2024-12-04
Medline Surgical Kits Recalled for Incorrect Needle and Suture Specifications
Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.
Product
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2025·2024-12-04
Philips dS Breast 7ch 3.0T MRI Coil Recalled for Patient Safety Hazard
Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.
Product
dS Breast 7ch 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2025·2024-12-04
Essenz HLM Heart-Lung Machines May Fail Due to Software Defect
The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.
Product
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2025·2024-12-04
Medline Epidural Catheter Kits Recalled Due to Connector Position Defect
Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.
Product
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2025·2024-12-04
MEDLINE Epidural Procedure Kits: Connector May Prevent Catheter Insertion
MEDLINE epidural trays used for labor anesthesia may have connectors that fail to fully open, preventing proper catheter insertion. The recall affects 2,592 units distributed across the US and internationally.
Product
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2025·2024-12-04
Surgical forceps and scissors handles recalled due to pin detachment
MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.
Product
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable han
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0535-2025·2024-12-04
VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.
Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0519-2025·2024-12-04
GE SIGNA Architect AIR MRI Systems Recalled for Elevated Acoustic Noise
GE Medical Systems is recalling three SIGNA Architect AIR MRI systems due to gradient coils that can produce elevated acoustic noise during scanning. The units were distributed to the US and 12 countries worldwide.
Product
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0549-2025·2024-12-04
Offset Cup Impactor Surgical Instruments Recalled for Weld Fracture
INCIPIO DEVICES is recalling 100 units of Offset Cup Impactor surgical instruments (Lot 24A0087) because the TIG weld does not meet specifications and has fractured. These instruments are used in hip surgery to position acetabular cup implants.
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2025·2024-12-04
Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0517-2025·2024-12-04
Discovery MR750w MRI Scanner Recalled for Elevated Acoustic Noise
GE Medical Systems is recalling 8 Discovery MR750w 3.0T MRI scanners because their gradient coils can produce elevated acoustic noise during scanning under specific conditions.
Product
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2025·2024-12-04
MEDLINE Epidural and Spinal Procedure Kits: Connector May Prevent Catheter Insertion
MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.
Product
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2025·2024-12-04
V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.
Product
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2025·2024-12-04
Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk
Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.
Product
Achieva TX Interventional Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2025·2024-12-04
Philips Breast MRI System Recalled for Patient Safety Risk
Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.
Product
dS Breast 7ch 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2025·2024-12-04
Smiths Medical Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk
Smiths Medical recalled its PORTEX Tracheal Tube Exchange Guide due to potential fluid ingress during reprocessing that may compromise disinfection standards and pose a contamination risk.
Product
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0541-2025·2024-12-04
Mammotrak Diagnostic Coil 1.5T Recalled Due to Patient Safety Concern
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
Product
Mammotrak Diagnostic Coil 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2025·2024-12-04
Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
Product
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0512-2025·2024-12-04
MEDLINE Procedure Kits: Connectors May Prevent Intended Catheter Insertion
MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US and internationally.
Product
MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0563-2025·2024-12-04
Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0580-2025·2024-12-04
MICRO-X Rover Mobile X-ray System environmental operating requirements
Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System due to environmental operating risks. The system requires strict temperature, humidity, and altitude controls to prevent capacitor malfunction, overheating, and unintended start-up.
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0530-2025·2024-12-04
AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall
Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.
Product
AMS Artificial Urinary Sphincter Control Pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0564-2025·2024-12-04
Baxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0553-2025·2024-12-04
Shimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit
Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.
Product
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2025·2024-12-04
MEDLINE Neuraxial Kit Connectors May Prevent Catheter Insertion
MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.
Product
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
Category
Medical Device
Distribution
Distributed nationwide

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4426–4450 of 13526