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Keystone Industries

Keystone Industries Recalls

All product recalls associated with Keystone Industries.

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Recall Summary

Total Recalls

751

Past Year

Class I (Serious)

100

Most Recent

Dec 2025

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 41–60 of 751 recalls

Topical Anesthetic Gel (Keystone Industries) – CGMP Vessel Defect (2024)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Class IIModerate

FDANov 14, 2024Nationwide• Keystone Industries

Ipana Topical Gel (Keystone Industries) – CGMP Vessel Defect (2024)

Class IIModerate

FDANov 14, 2024Nationwide• Keystone Industries

Perio Maintenance Rinse (Keystone) – Subpotent Drug (2024)

1 234 5...38

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Subpotent Drug

Class IIModerate

FDAOct 17, 2024Nationwide• Keystone Industries

E-One Typhoon N (E-One) – Engine Crossmember Failure (2024)

E-One Incorporated (E-One) is recalling certain 2020-2024 Cyclone 2, Typhoon N, 2021- 2024 Cyclone N, and 2021 Quest 2 vehicles. The engine crossmember may break, allowing the cooling fan to contact the fan shroud and become damaged.

NHTSAOct 11, 2024Nationwide• E-ONE

Medline Maxorb Extra Alginate Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

McKesson Calcium Alginate Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

Hollister CalciCare Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

E-One Cyclone II (E-One) – Engine Crossmember Risk (2024)

E-One Incorporated (E-One) is recalling certain 2022-2023 Cyclone 2, 2022-2024 Cyclone N, and Typhoon N vehicles. The engine crossmember may break, allowing the cooling fan to contact the fan shroud and become damaged.

NHTSAAug 30, 2024Nationwide• E-ONE

Colorado Trailer (Keystone) – Structural Body Issue (2024)

Keystone RV Company (Keystone) is recalling certain 2024 Springdale 245ML, Hideout 24L0F, Aspen Trail 260THLOFT, 360THLOFT, and Colorado 360THLOFT travel trailers. The metal sidewall may be incorrectly attached and come loose during transit.

NHTSAJul 9, 2024Nationwide• KEYSTONE

E-One Cyclone N (E-One) – Lower Control Arm Risk (2024)

E-One Incorporated (E-One) is recalling certain 2024 Cyclone N and Typhoon N vehicles equipped with an independent front suspension assembly. The lower control arm retention bolts could become brittle and break after being tightened.

NHTSAJul 2, 2024Nationwide• E-ONE

Greiner Bio-One North America, Inc.: VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x...

The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.

FDAMay 14, 2024Nationwide• Greiner Bio-One North America, Inc.

2023 KEYSTONE FUZION Recall: EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP

Fire/Burn Risk

Keystone RV Company (Keystone) is recalling certain 2021-2023 Montana, 2021-2022 Montana High Country, 2022-2024 Fuzion, 2021 Crossroads Cruiser, and 2024 Dutchmen Aspen Trail LOFT vehicles. The LED backlight circuit board in the cooktop range may fail, causing the board to overheat.

NHTSAMar 27, 2024Nationwide• KEYSTONE

2024 E-ONE CYCLONE N Recall: ELECTRICAL SYSTEM

Fire/Burn Risk

E-One Incorporated (E-One) is recalling certain 2024 Commercial, Cyclone N, Typhoon N, and Typhoon EV vehicles equipped with Hercules HC 1.7 multiplex nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.

NHTSAMar 12, 2024Nationwide• E-ONE

2024 KEYSTONE SPRINGDALE Recall: STRUCTURE

Keystone RV Company (Keystone) is recalling certain 2024 Hideout 175BH, 177RD, 178RB, 179RB, 181BH, and 2024 Springdale 1700FQ, 1760 FQ, 1800BH, 1810BH, 1860SS, 2010BH travel trailers. The propane cylinder holder may have an insufficient welds, allowing the propane cylinder to detach.

NHTSAFeb 19, 2024Nationwide• KEYSTONE

2022 E-ONE CYCLONE II Recall: STEERING

E-One Incorporated (E-One) is recalling certain 2022-2023 Cyclone 2, Cyclone N, Typhoon N, and 2023 Cyclone E vehicles. The steering assist bracket may have been machined incorrectly.

NHTSAJan 12, 2024Nationwide• E-ONE

2022 E-ONE TYPHOON N Recall: ELECTRICAL SYSTEM:WIRING

Fire/Burn Risk

E-One Incorporated (E-One) is recalling certain 2021-2023 ARFF, Cyclone N, 2020-2024 Commercial, 2020, 2022-2023 Cyclone 2, 2023 Cyclone E, 2022 Typhoon, and 2020-2023 Typhoon N vehicles. In the event of a short circuit or wiring failure, the firmware in the vehicle multiplex system may fail to shut off the output pin, resulting in overloaded electrical circuits.

NHTSAJan 8, 2024Nationwide• E-ONE

Greiner Bio-One North America, Inc.: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, ...

Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

FDADec 12, 2023Nationwide• Greiner Bio-One North America, Inc.

Keystone Industries: KeySplint Hard Clear - Indicated for the fabrication of o...

Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

FDANov 20, 2023Nationwide• Keystone Industries

OLEA MEDICAL 93 AVANUE DU SORBIER, ZONE ATHELIA IV LA CIOTAT France: Functional MR V1.0

When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.

FDAAug 10, 2023MA, MI• OLEA MEDICAL 93 AVANUE DU SORBIER, ZONE ATHELIA IV LA CIOTAT France

Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany: Henke-Ject-2 part luer sterile single use syringes - used...

Sterile barrier might be damaged compromising the sterility of the device.

FDAJul 27, 2023Nationwide• Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany