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

3526–3550 of 39987

ModerateFDA (Devices)·Z-2172-2025·2025-08-06
Sterilizable Drill Stop Kits were shipped containing incorrect components
The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.
Product
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2195-2025·2025-08-06
LYFO-DISK M. canis single packs may fail to recover the organism
LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Product
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2197-2025·2025-08-06
IontoPatch 80 nonwoven pads do not absorb the saline solution
IontoPatch 80 On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 63,936 units affected.
Product
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2219-2025·2025-08-06
ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled
ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.
Product
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2193-2025·2025-08-06
Sprinter Cart infusion poles do not meet IEC 60601-1 labeling requirements
Sprinter Cart and Sprinter Cart XL Infusion Poles are being recalled because the device does not comply with the labeling requirements of international standard IEC 60601-1. 7,754 units affected.
Product
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2196-2025·2025-08-06
IontoPatch STAT nonwoven pads do not absorb the saline solution
IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.
Product
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2231-2025·2025-08-06
3M Ranger irrigation fluid warming set notice clarifies flow rates
The 3M Ranger Irrigation Fluid Warming Set is subject to a notice issued to clarify flow rates related to the inlet fluid temperature. 186,880 units are affected.
Product
3M Ranger Irrigation Fluid Warming Set, REF 24750
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2192-2025·2025-08-06
Phasor neurosurgical drills may have a reverse battery orientation
The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.
Product
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-2169-2025·2025-07-30
CareLink SmartSync limited the window to abort a high voltage therapy
Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
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-2168-2025·2025-07-30
SmartSync Patient Connector limited the window to abort high voltage therapy
The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
Product
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 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 M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2025·2025-07-30
SIGNA Architect AIR gradient coils can produce acoustic noise above limit
GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
SIGNA Architect AIR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2025·2025-07-30
BD COR system software issue could produce possible false negative results
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
Product
BD COR System Software. Model Number: 444829.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2025·2025-07-30
Stryker StrykeFlow suction irrigator may leak solution into the handpiece
The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
Product
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2025·2025-07-30
Endosee system convenience trays label non-sterile iodine pouches as sterile
Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.
Product
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2025·2025-07-30
Endosee convenience kits label non-sterile iodine pouches as sterile
Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.
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-2134-2025·2025-07-30
Azurion 7 M20 C-arm gearbox mounting bolts may become loose
The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2025·2025-07-30
EMPOWR dual mobility OD42 bearings were packaged with the wrong implant
EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.
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-2165-2025·2025-07-30
Biofinity XR Toric contact lens blisters may have a leaking seal
Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.
Product
Biofinity XR Toric Contact Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2025·2025-07-30
Biofinity Toric Multifocal contact lens blisters may have a leaking seal
Biofinity Toric Multifocal Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 827 units are affected.
Product
Biofinity Toric Multifocal Contact Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2025·2025-07-30
SIGNA PET/MR gradient coils can produce acoustic noise above the limit
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
SIGNA PET/MR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2025·2025-07-30
Nellcor bedside SpO2 monitor alarms may not be heard or recognized
The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.
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
HighFDA (Devices)·Z-2135-2025·2025-07-30
HSG procedure trays label non-sterile iodine pouches as sterile
HSG Procedure Trays are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 171 units are affected.
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-2147-2025·2025-07-30
EMPOWR dual mobility poly bearings were packaged with the wrong implant
EMPOWR Acetabular Dual Mobility Poly Bearings are being recalled because of a packaging discrepancy in which incorrect implants were packaged, discovered through a customer complaint. 20 units 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
HighFDA (Devices)·Z-2153-2025·2025-07-30
Medline labor triage kits contain ChloraPrep applicators with open seals
Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.
Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2171-2025·2025-07-30
Stryker StrykeFlow irrigator with tip may leak solution into handpiece
The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
Product
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Category
Medical Device
Distribution
Distributed nationwide

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3526–3550 of 39987