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

2351–2375 of 27346

HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2025·2025-08-20
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2025·2025-08-20
Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2182-2025·2025-08-13
BritePro Solo mini handles and blades may not illuminate as intended
BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2180-2025·2025-08-13
BD Alaris pump infusion sets may perform outside established flow ranges
BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Product
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2183-2025·2025-08-13
BritePro Solo laryngoscope handles and blades may not illuminate as intended
BritePro Solo Single-Use Fiber Optic Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-36
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2187-2025·2025-08-13
BritePro Solo fiber optic laryngoscope handles may not illuminate properly
BritePro Solo Single-Use Fiber Optic Laryngoscope Handles, REFs 040-310AU and 040-310U, are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2186-2025·2025-08-13
BritePro Solo mini laryngoscope handles may not illuminate as intended
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2185-2025·2025-08-13
BritePro Solo stubby laryngoscope handles may not illuminate as intended
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Product
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2184-2025·2025-08-13
BritePro Solo mini Miller blade handles may not illuminate as intended
BritePro Solo Mini with Pro Miller Blade Size 1.5 is being recalled because the laryngoscope handles may not illuminate as intended.
Product
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2129-2025·2025-08-13
Plum Duo infusion system interface may become unresponsive during programming
The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.
Product
Plum Duo Infusion System, List Number: 400020401
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2176-2025·2025-08-13
Microbore extension sets are labeled as having an air eliminating filter
Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.
Product
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Category
Medical Device
Distribution
32 states
SevereFDA (Devices)·Z-2179-2025·2025-08-13
BD Alaris pump modules may perform outside established flow rate ranges
BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2239-2025·2025-08-13
Pinnacle 3 radiation planning software may miscalculate stopping power ratio
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2025·2025-08-13
Size 2 Guedel airways may carry small burrs that could detach
One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.
Product
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2277-2025·2025-08-13
Stryker SmartPump tourniquet cuff flanges may detach from the bladder
Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.
Product
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2025·2025-08-13
UIBC assay does not meet its labeled hemoglobin interference claim
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
Product
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2276-2025·2025-08-13
Guedel airways may carry small burrs that could detach and be inhaled
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2274-2025·2025-08-13
DASH COVID and flu tests may give a false negative result
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
Product
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2272-2025·2025-08-13
epoc BUN test cards may show a negative sodium bias
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
Product
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2160-2025·2025-08-06
HME TwinStar HEPA Plus filters show a slow rising CO2 curve
HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.
Product
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2159-2025·2025-08-06
SafeStar 55 Plus breathing filters show a slow rising CO2 curve
SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.
Product
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2167-2025·2025-08-06
Hamilton coaxial breathing circuits may have a crack in blue tubing
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
Product
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2161-2025·2025-08-06
SafeStar 60A Plus breathing filters show a slow rising CO2 curve
SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.
Product
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2164-2025·2025-08-06
Automated Impella Controllers may not detect a connected Impella pump
The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.
Product
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Pr
Category
Medical Device
Distribution
Distributed nationwide

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2351–2375 of 27346