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Denver Solutions, LLC DBA Leiters Health

Denver Solutions, LLC DBA Leiters Health Recalls

All product recalls associated with Denver Solutions, LLC DBA Leiters Health.

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Recall Summary

Total Recalls

1000

Past Year

566

Class I (Serious)

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 1361–1380 of 7756 recalls

Phenylephrine HCl Syringes (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

FDAFeb 21, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Phenylephrine HCl IV Bag (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

FDAFeb 21, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Phenylephrine HCl IV Bag (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

1...67 686970 71...388

Page 69 of 388Next

FDA

Feb 21, 2023

Nationwide

• Denver Solutions, LLC DBA Leiters Health

Raystation Treatment Planning (RaySearch) - Collimator Angle (2023)

It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

FDAFeb 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Brainlab ExacTrac Software (Brainlab) - Breath Hold Functionality (2023)

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

FDAFeb 14, 2023Nationwide• Brainlab AG Olof-palme-str. 9 Munich Germany

FreeStyle Libre Reader (Abbott) – Battery Fire Risk (2023)

Fire/Burn Risk

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

FDAFeb 13, 2023Nationwide• Abbott Diabetes Care, Inc.

BraunAbility Turny Child Seat (Braun) – Mobility Equipment Issue (2023)

Braun Corporation (Braun) is recalling certain child seat weldments sold as accessory parts to the BraunAbility Turny Seat, model number 225 and part number TAS-01223. The child restraint lower anchors may have been manufactured with improper welds.

NHTSAFeb 13, 2023Nationwide• BRAUN ABILITY TURNY

FreeStyle Libre Reader (Abbott) – Battery Fire Risk (2023)

Fire/Burn Risk

FDAFeb 13, 2023Nationwide• Abbott Diabetes Care, Inc.

FreeStyle Libre 3 App (Abbott) – Signal Loss Risk (2023)

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

FDAFeb 9, 2023Nationwide• Abbott Diabetes Care, Inc.

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Class IIModerate

FDAFeb 8, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

injeTAK Needles (Labories) – Packaging Damage Concern (2023)

The packaging may be damaged, compromising the sterile barrier.

FDAFeb 7, 2023Nationwide• Labories Medical Technologies

Hoffmann LRF Transport Strut (Stryker) – Thread Pitch Issue (2023)

Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.

FDAFeb 7, 2023Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Arroyabe Bonito Flakes (Culinary Collective) – fish bone risk (2023)

Dried fish bones were found in product.

Class IIModerate

FDAFeb 6, 2023IN, UT, WA• Power Selles Imports dba Culinary Collective

Bistro To Go Fresh Cut Pineapple Chunks (Fresh Creative Cuisine) – potential contamination (2023)

Listeria

On 02/03/2023, FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine of Baltimore, MD is initiating a recall of various products sold from January 24, 2023 through January 30, 2023 because the products have the potential to be contaminated with Listeria monocytogenes .

Class IHigh

FDAFeb 3, 2023CT, DE, MD +8 more• FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine