Search Product Recalls

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Suntegrity Sunscreen (Synchronicity) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

Class IHigh

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Gray Revision Instrument Tray (Howmedica) – Case Design Issue (2024)

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

High

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

Surgical Image Guidance (Alcon) – Software Movement Error (2024)

After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.

Low

FDAMay 23, 2024Nationwide• Alcon Research LLC Aspex Facility

Dexamethasone Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

FDAMay 23, 2024Nationwide• Eugia US LLC

Zoledronic Acid Injection (Dr. Reddy's) – Sterility Concern (2024)

Lack of Assurance of Sterility: Leaking vials

FDAMay 23, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

HRIS Storage Tray (Howmedica) – Case Design Problem (2024)

Low

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Endo Model M Tibial Components (Waldemar Link) – Surgical Screw Issue (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Avalon Ultrasound Transducer (Philips) – Fetal Measurement Error (2024)

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

FDAMay 22, 2024Nationwide• Philips North America Llc

DxI 9000 Access Analyzer (Beckman Coulter) – Laboratory System Compatibility (2024)

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Abbott Infinity 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

FDAMay 22, 2024Nationwide• Abbott Medical

Endo Model SL Tibial Components (Waldemar Link) – Surgical Screw Problem (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

Abbott Infinity 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

FDAMay 22, 2024Nationwide• Abbott Medical

Eptifibatide Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Class IIILow

FDAMay 22, 2024Nationwide• Eugia US LLC

OSSOS-SANS Tablets (MexHealth) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

FDAMay 22, 2024Nationwide• MexHealth LLC

Beckman Coulter DxI 9000 Analyzer (Beckman Coulter) – System Connectivity (2024)

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

BD Alaris System Manager (CareFusion) – Wireless Data Transmission (2024)

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.