Egress Capital Partners Inc. Recalls

No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)

FDASep 18, 2025CA, CT, FL +3 more• Egress Capital Partners Inc.

Taproom Gourmet Broadway Mix (Egress) – Undeclared Allergens (2025)

No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)

FDASep 18, 2025CA, CT, FL +3 more• Egress Capital Partners Inc.

Madison Mix (Taproom Gourmet) – Undeclared Allergens (2025)

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No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)

Class IIModerate

FDASep 18, 2025CA, CT, FL +3 more• Egress Capital Partners Inc.

SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

FDASep 17, 2025Nationwide• Beckman Coulter Inc.

InSure ONE Test (Enterix) – False Negative Risk (2025)

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

FDASep 17, 2025Nationwide• Enterix, Inc.

Oral Probe (Baxter) – Temperature Reading Error (2025)

Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.

FDASep 17, 2025Nationwide• Baxter Healthcare Corporation

BrainSTORM Surgical Planner (Surgical Theater) – Image Alignment Issue (2025)

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

SyncAR Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

SpineAR Surgical Navigation (Surgical Theater) – Image Fusion Problem (2025)

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

FDASep 16, 2025Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

FDASep 16, 2025CA• Gansu Zhaofeng Agricultural Development Co., Ltd.

Undeclared allergen (wheat).

Class IIILow

Surgical Navigation Platform (Surgical Theater) – Image Misalignment Risk (2025)

FDASep 16, 2025Nationwide• IntegraDose Compounding Services LLC

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Class IHigh

Levothyroxine Tablets (Accord) – Subpotent Medication (2025)

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

FDASep 16, 2025Nationwide• ACCORD HEALTHCARE, INC.

Surgical Planner (Surgical Theater) – Image Fusion Misalignment (2025)

Endo Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

FDASep 15, 2025AK, CA, FL +5 more• FUJIFILM Healthcare Americas Corporation

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Failed Tablet/Capsule Specifications

FDASep 15, 2025Nationwide• Graviti Pharmaceuticals Private Limited

Carbamazepine Tablets (Amerisource) – Dissolution Issue (2025)

Failed Dissolution Specifications.