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Stonewall Kitchen, LLC

Stonewall Kitchen, LLC Recalls

All product recalls associated with Stonewall Kitchen, LLC.

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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 4081–4100 of 37665 recalls

Cinnamon Sugar Doughnut Mix (Stonewall Kitchen) – Undeclared Wheat (2024)

Undeclared Gluten

Product contains undeclared wheat.

Class IHigh

FDAMar 7, 2024AZ, AR, CA +41 more• Stonewall Kitchen, LLC

PowerSeal 37cm Curved Jaw Sealer (Olympus) – Incomplete Seal Cycle (2024)

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

High

FDAMar 7, 2024Nationwide• Olympus Corporation of the Americas

Exactech Equinoxe Humeral Liner (Exactech) – Packaging Nonconformance (2024)

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

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High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Exactech Equinoxe Humeral Liner (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Exactech Equinoxe Reverse Shoulder Liner (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Tablo Hemodialysis System (Outset Medical) – Tubing Replacement (2024)

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

High

FDAMar 6, 2024AL, AK, AZ +39 more• Outset Medical, Inc.

Exactech Equinoxe Cage Glenoid (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Ground Cinnamon (Colonna Brothers) – Lead Levels (2024)

Elevated lead levels in cinnamon

Class IIModerate

FDAMar 6, 2024Nationwide• Colonna Brothers Inc.

Infinity Resection Adjustment Block (Wright Medical) – Manufacturing Defect (2024)

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Moderate

FDAMar 6, 2024NE, TX• Wright Medical Technology, Inc.

Thai Jasmine Rice (Otis McAllister) – Glass Fragment (2024)

Foreign object; piece of glass.

Class IIModerate

FDAMar 6, 2024OR, TX, UT +1 more• Otis McAllister

Bed Assist Bars (Medline) – Compliance Standard Issue (2024)

Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails) and failed to meet all mandatory requirements outlined in these standards.

High

FDAMar 5, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Hill-Rom PRO+ MRS Surface (Baxter) – Service Record Inconsistencies (2024)

Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.

High

FDAMar 5, 2024Nationwide• Baxter Healthcare Corporation

Clinical Chemistry Calibration Serum (Randox) – Phosphate Bias (2024)

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Moderate

FDAMar 5, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Tank Crack (2024)

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

High

FDAMar 5, 2024Nationwide• Beckman Coulter, Inc.

t:connect Mobile App (Tandem Diabetes) – App Crash Risk (2024)

During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.

Very High

FDAMar 5, 2024Nationwide• Tandem Diabetes Care, Inc.

Betimol (Thea Pharma) – sterility issue (2024)

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Class IIModerate

FDAMar 5, 2024Nationwide• Thea Pharma, Inc.

OptiCross Coronary Imaging Catheter (Boston Scientific) – Image Quality Issue (2024)

Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

Moderate

FDAMar 5, 2024Nationwide• Boston Scientific Corporation

Neria Soft Infusion Set (Unomedical) – Incorrect Instructions (2024)

Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.

Low

FDAMar 5, 2024Nationwide• Unomedical A/S Osted Aholmvej 1