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Showing 3681–3700 of 4465 results

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

Lack of sterility assurance for closed suction catheter systems

FDAMar 19, 2025Nationwide• Avanos Medical, 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

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.

Low

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Vermeer LPSGT (Vermeer) – trailer frame crack risk (2025)

Vermeer Manufacturing Company (Vermeer) is recalling certain 2020-2025 LPSDT, LPSGT, and LPXDT vacuum excavator trailers. The trailer frame may crack or break, reducing the trailer's stability while being towed.

NHTSAMar 19, 2025Nationwide• VERMEER

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

META-TAN Screw Kit (Smith & Nephew) – compression screw issue (2025)

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

FDAMar 18, 2025Nationwide• Smith & Nephew, Inc.

External Defibrillators DDU-2200 (Defibtech) – translation missing (2025)

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

FDAMar 18, 2025Nationwide• Defibtech, LLC

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

Tesla Cybertruck (Tesla) – light bar detachment (2025)

Tesla, Inc. (Tesla) is recalling certain 2024-2025 Cybertruck vehicles. The light bar can delaminate and detach from the vehicle.

NHTSAMar 18, 2025Nationwide• TESLA

External Defibrillators DDU-100 (Defibtech) – translation missing (2025)

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

FDAMar 18, 2025Nationwide• Defibtech, LLC

Amplatzer TorqVue LP Delivery System (Abbott) – shaft breach (2025)

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

FDAMar 17, 2025Nationwide• Abbott

R123 Ecopia Tire (Bridgestone) – trailer vehicle issue (2025)

Bridgestone Americas Tire Operations (BATO) is recalling certain R123 Ecopia tires, size 295/75R22.5, designed for use on commercial trailer vehicles. The tires may have been manufactured incorrectly with one of the three stabilizer ply belts applied in the wrong orientation. As such, these tires fail to comply with Federal Motor Vehicle Safety Standard (FMVSS) number 119, "New pneumatic tires - other than passenger cars."

NHTSAMar 17, 2025Nationwide• BRIDGESTONE

Amplatzer TorqVue LP Catheter (Abbott) – shaft breach (2025)

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

FDAMar 17, 2025Nationwide• Abbott

DxC 500 AU Analyzer (Beckman Coulter) – result processing error (2025)

The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

FDAMar 17, 2025Nationwide• Beckman Coulter Inc.

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Failed dissolution specifications: lower than specifications

Class IIModerate

FDAMar 17, 2025Nationwide• BIOCON PHARMA INC

Gold Garlic Powder (Pacific Meridian) – Metal Contamination (2025)

Potential contamination with foreign objects (metal)

Class IIModerate

FDAMar 17, 2025CA, IL, TX• Pacific Meridian Group, LLC

Dried Cranberries (Victor Packing) – Mislabeled Carbohydrates (2025)

Misbranded - label states 2g total carbohydrates instead of 27g

Class IIModerate

FDAMar 17, 2025CA, FL, IL +6 more• Victor Packing Inc.

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

Ford F-350 SD (Ford) – transmission shifter issue (2025)

Ford Motor Company (Ford) is recalling certain 2025 Super Duty F-250, F-350, and F-450 vehicles. The steering column shifter may have been improperly welded and detach from the steering column.

NHTSAMar 14, 2025Nationwide• FORD

DORO Easy-Connect Navigator (Pro-Med) – reference array issue (2025)

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

FDAMar 14, 2025Nationwide• Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany

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