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

2701–2725 of 13380

HighFDA (Devices)·Z-2142-2025·2025-07-30
Ellik Evacuator Tubing Recalled Due to Sterilization Instruction Discrepancies
Olympus is recalling tubing for the Ellik Evacuator due to discrepancies between sterilization instructions in Japanese language package inserts and the manufacturer's Instructions for Use.
Product
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2169-2025·2025-07-30
Medtronic CareLink SmartSync Device Manager software abort button defect recall
Medtronic is recalling CareLink SmartSync Device Manager software versions due to a defective abort button. The abort button does not properly stop induction testing, limiting users' ability to cancel high voltage therapy delivery.
Product
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2025·2025-07-30
Medline Convenience Kits Recalled for Potential Sterility Breach Risk
Medline Convenience Kits containing BD ChloraPrep Clear applicators are recalled due to potential open seals on packaging that may compromise sterility and lead to infection risk during surgical procedures.
Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2153-2025·2025-07-30
Medline Convenience Kits with BD ChloraPrep recalled due to sterility breach risk
Medline Convenience Kits containing BD ChloraPrep applicators are being recalled due to potential open seals that could breach sterility and increase infection risk. The recall affects 960 units distributed in California, Florida, Pennsylvania, and Texas.
Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2146-2025·2025-07-30
Ellik Evacuator surgical device sterilization instructions differ between language versions
Olympus is recalling Ellik Evacuator Model 191-NRS due to discrepancies between sterilization instructions in Japanese-language product inserts and the manufacturer's English Instructions For Use. Sterilization instruction discrepancies may affect proper device preparation before use.
Product
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2138-2025·2025-07-30
Brain Monitor Recall for Incorrect Left-Right Data Labeling
Natus Brain Monitor devices are being recalled due to labeling errors where the left side display shows impedance data for the right side. Two complaints have been received; no injuries reported.
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2131-2025·2025-07-30
MRI Gradient Coils Produce Excessive Acoustic Noise During Scanning
GE HealthCare is recalling certain SIGNA Architect AIR MRI systems because gradient coils can produce acoustic noise exceeding 99dB during scanning, surpassing safe limits even with required hearing protection.
Product
SIGNA Architect AIR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2025·2025-07-30
Ellik Evacuator Glass Body Sterilization Instruction Discrepancy Recall
Olympus recalls Model 190A Ellik Evacuator glass bodies due to discrepancies between sterilization instructions in Japanese and English product materials. Healthcare facilities should verify correct sterilization procedures with the manufacturer.
Product
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2137-2025·2025-07-30
Endosee System Convenience Kits recalled for non-sterile iodine pouches
CooperSurgical is recalling 475 units of Endosee System Convenience Kits with IV Tube due to non-sterile iodine pouches labeled as sterile. The kits were distributed nationwide to healthcare facilities.
Product
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2025·2025-07-30
BD COR System Software Potential False Negative Results in Diagnostic Testing
BD COR System Software has a potential functionality issue with the Over labeling feature that could produce false negative results. The 7 affected systems are distributed in Florida, Texas, Michigan, Sweden, and Belgium.
Product
BD COR System Software. Model Number: 444829.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2025·2025-07-30
Portable X-ray systems recalled for inadequate radiation safety spacing
Certain DIGIMED DIOX-602 portable X-ray systems do not meet the minimum source-to-skin distance safety requirement of 18 centimeters. This non-compliance may increase patient radiation exposure during diagnostic imaging.
Product
Portable X-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2133-2025·2025-07-30
SIGNA PET/MR gradient coils produce excessive acoustic noise during scanning
GE Medical Systems recalled SIGNA PET/MR imaging systems because gradient coils produce acoustic noise exceeding 99 decibels during scanning, surpassing established safety limits even with hearing protection.
Product
SIGNA PET/MR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2025·2025-07-30
Medical Device Recall: Non-Sterile Iodine Pouches Mislabeled as Sterile
CooperSurgical is recalling 991 Endosee System Convenience Kits (Model ES-TRAY) because the iodine pouches are non-sterile but labeled as sterile on the peel-away lid labels. The affected devices were distributed nationwide.
Product
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2025·2025-07-30
Ellik Evacuator Adapter sterilization instructions differ between Japanese and English
Olympus recalls Ellik Evacuator Adapter 190-NRS due to discrepancies between Japanese and English sterilization instructions that could lead to improper device sterilization.
Product
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2148-2025·2025-07-30
EMPOWR Hip Implant Components Recalled Due to Packaging Discrepancy
Encore Medical is recalling EMPOWR Dual Mobility hip acetabular components due to incorrect tibial inserts being packaged with products. The discrepancy was discovered through a customer complaint.
Product
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femora
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2135-2025·2025-07-30
HSG Procedure Trays With Incorrect Sterility Labeling on Iodine Pouches
CooperSurgical HSG Procedure Trays contain non-sterile iodine pouches incorrectly labeled as sterile. The mislabeling affects 171 units distributed nationwide.
Product
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2025·2025-07-30
Covidien Nellcor Bedside SpO2 Patient Monitoring System Alarms May Not Sound
The Covidien Nellcor Bedside SpO2 Patient Monitoring System may not produce audible alarms, preventing caregivers from responding to low oxygen saturation or sensor disconnection. This can delay treatment and cause respiratory failure or arrhythmia.
Product
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2147-2025·2025-07-30
Encore Medical Recalls EMPOWR Dual Mobility Hip Implants for Packaging Error
Encore Medical is recalling EMPOWR Dual Mobility hip implants due to incorrect components being packaged. Approximately 35 devices are affected.
Product
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femora
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-2157-2025·2025-07-30
Sodium Chloride Irrigation Solution Missing Sterilization Process Monitoring Audit
Bridge to Life EasiSlush (0.9% sodium chloride irrigation) has been recalled because three lots did not complete required quarterly sterilization process monitoring audits on time during Q1 2024. Routine lot testing was completed properly.
Product
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2134-2025·2025-07-30
Philips Azurion 7 M20 X-Ray System C-Arm Gearbox Bolts May Loosen
Philips is recalling Azurion 7 M20 fluoroscopic X-ray systems due to potential loosening of bolts connecting the gearbox to the C-arm mounting flange. No injuries have been reported.
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2144-2025·2025-07-30
Ellik Evacuator surgical device recall due to sterilization instruction discrepancy
Olympus Corporation is recalling Ellik Evacuator surgical devices due to discrepancies between sterilization instructions in Japanese product package inserts and the English product Instructions For Use.
Product
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2140-2025·2025-07-30
Olympus endoscope seals recalled for sterilization instruction discrepancy
Olympus Corporation recalls 41 Green Silicone Seal accessories (CS-G7) for endoscopes distributed to Japan. Sterilization instructions differ between Japanese product inserts and manufacturer documentation, potentially affecting proper device sterilization.
Product
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and mini
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2095-2025·2025-07-23
Baxter Infusion Pump Recall: SIGMA Spectrum V6 Software Defect
Baxter Healthcare recalls 14 SIGMA Spectrum Infusion Pump V6 units due to incorrect software version. The recalled units were distributed to 10 US states.
Product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-2128-2025·2025-07-23
Medtronic CareLink SmartSync Device Manager software recalled for erroneous reset message
The Medtronic CareLink SmartSync Device Manager software displays a false electrical reset message, potentially prompting unnecessary device removal. Two patients have undergone unnecessary device explant procedures due to this error.
Product
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobal
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2102-2025·2025-07-23
i-view Video Laryngoscope Recalled Due to Depleted Battery Risk
Intersurgical Inc is recalling the i-view video laryngoscope (Model 8008000) due to the potential for faulty devices caused by depleted batteries. A total of 2,152 affected units were distributed across the United States.
Product
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Category
Medical Device
Distribution
17 states

How to read this listing

Filters

2701–2725 of 13380