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Showing 2501–2520 of 3039 results

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Blood Pressure Cuff Kit (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

Phasor Drill (Phasor Health) – battery orientation risk (2025)

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

FDAMar 21, 2025AZ, AR, CA +25 more• Phasor Health, LLC

Connex Wall System (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Low

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

CareStation 750 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Spot Vital Signs 4400 (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

DxC 500 AU Analyzer (Beckman Coulter) – calibration software error (2025)

Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.

FDAMar 20, 2025AL, CA, GA +14 more• Beckman Coulter Inc.

Cerene Cryotherapy Device (Channel Medsystems) – gasket seal issue (2025)

Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device

FDAMar 20, 2025Nationwide• Channel Medsystems, Inc.

GenetiSure Dx Kit (Agilent) – DNA labeling component (2025)

DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

FDAMar 20, 2025MA• Agilent Technologies, Inc.

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

FDAMar 20, 2025Nationwide• Abbott Molecular, Inc.

VASOVIEW HEMOPRO 2 (Maquet) – ceramic C-Ring breakage (2025)

There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

FDAMar 20, 2025Nationwide• Maquet Cardiovascular, LLC

Procedure Kits (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Turkey BLT on Sourdough (Hearn Kirkwood) – Incorrect Sandwich (2025)

Undeclared Allergen

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

Class IIModerate

FDAMar 19, 2025NY• The Coastal Companies DBA Hearn Kirkwood

Quantum Informatics VIPER (Spectrum Medical) – FDA clearance (2025)

Medical device software marketed without FDA clearance .

FDAMar 19, 2025AL, AZ, AR +35 more• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Sterile Water (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Ballard Closed Suction Catheters (Avanos) – sterility concern (2025)

Lack of sterility assurance for closed suction catheter systems

FDAMar 19, 2025Nationwide• Avanos Medical, Inc.

Sterile Normal Saline (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Brioche Bread and Buns (Baking Group) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (soy, milk) and Yellow #5

Class IIModerate

FDAMar 19, 2025TX• Harvey Investments LLC / The Baking Group

epoc BGEM Crea Test Card (Siemens) – pH result discrepancy (2025)

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

FDAMar 19, 2025Nationwide• Siemens Healthcare Diagnostics Inc

epoc BGEM BUN Test Card (Siemens) – pH result discrepancy (2025)

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

FDAMar 19, 2025Nationwide• Siemens Healthcare Diagnostics Inc

CELL-DYN Ruby (Abbott) – reagent expiration error (2025)

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

FDAMar 18, 2025Nationwide• Abbott Laboratories

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