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FNA Group Inc., of Pleasant Prairie, Wisconsin

FNA Group Inc., of Pleasant Prairie, Wisconsin Recalls

All product recalls associated with FNA Group Inc., of Pleasant Prairie, Wisconsin.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4521–4540 of 37665 recalls

Simpson Gas Pressure Washers (FNA Group) – burn hazard (2023)

This recall involves Simpson Gas Pressure Washers with model number PS61264. The pressure washers are black in color. The Simpson logo, "Pro Series" and 4400 PSI are printed on the handle of the unit. The model number is printed on a silver label on the unit's frame.

CPSCDec 28, 2023Nationwide• FNA Group Inc., of Pleasant Prairie, Wisconsin

FentaNYL Citrate IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

FentaNYL Citrate Large IV Solution (Denver Solutions) – Double Dose Risk (2023)

1...225 226227228 229...1884

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Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Class IHigh

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

VANCOmycin HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin IV Bag (Denver Solutions) – Dosage Malfunction (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Wellsley Farms Mini Quiches (Fillo Factory) – foreign material (2023)

Possible foreign material (aluminum)

Class IIModerate

FDADec 28, 2023CT, FL, IN +4 more• The Fillo Factory Inc.

TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

FDADec 27, 2023CA, CO, FL +13 more• TruAbutment Inc.

Battle Motors LET2 (Battle Motors) – steering linkage fault (2023)

Battle Motors, Inc. (Battle Motors) is recalling certain 2023-2024 Let2 trucks. The drag link connecting the steering gear to the roadside steering knuckle may become deformed or break.

NHTSADec 27, 2023Nationwide• BATTLE MOTORS

GE Lullaby Incubator (GE Healthcare) – bedside panel issue (2023)

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

FDADec 26, 2023Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

GE Neonatal Incubator (GE Healthcare) – bedside panel problem (2023)

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

FDADec 26, 2023Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

GE Care Plus Hood (GE Healthcare) – bedside panel issue (2023)

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

FDADec 26, 2023Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

Power Knee (Ossur) – battery failure risk (2023)

Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.

FDADec 26, 2023Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Divalproex Sodium Extended-Release Tablets (Amneal) – Dissolution Failure (2023)

Failed dissolution specifications

Class IIModerate

FDADec 26, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

FDADec 26, 2023Nationwide• Amerisource Health Services LLC

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

FDADec 26, 2023Nationwide• GE Medical Systems, SCS

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

FDADec 22, 2023Nationwide• Howmedica Osteonics Corp.

Aligned Ocular Pack (Windstone) – saline sterility concern (2023)

Sterility assurance for saline included in surgical kits cannot be guaranteed.

FDADec 22, 2023CA, FL, IL• Windstone Medical Packaging, Inc.

Aligned Closure Kit (Windstone) – saline sterility concern (2023)

Sterility assurance for saline included in surgical kits cannot be guaranteed.

FDADec 22, 2023CA, FL, IL• Windstone Medical Packaging, Inc.