CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used…
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred…
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- CareFusion
- Product
- BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide including Puerto Rico, Guam, American…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More CareFusion recalls
- 2026-01-14
USCareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01,…
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR,…Official notice →- 2026-01-07
- US
- 2025-12-31
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis…
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of CO, IN, OH,…Official notice → - 2025-11-05
- US
CareFusion 303, Inc. recalls BD Pyxis Pro MedStation Main, REF: 1155-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA · DeviceCareFusion 303, Inc.Worldwide distribution - US Nationwide and the countries of Canada, United…Official notice → - 2025-10-15
- US
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana…Official notice → - 2025-09-03
- US
CareFusion 303, Inc. recalls BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower /…
Antivirus software was not consistently installed on impacted devices during the implementation process.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-26
- US
Becton Dickinson & Company recalls BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
FDA · DeviceBecton Dickinson & CompanyWorldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - US
ELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0…
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
FDA · DeviceELEKTA SOLUTIONS ABWorldwide - U.S. Nationwide distribution in the state of NM and the countries…Official notice → - US
TMJ Solutions Inc recalls TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
FDA · DeviceTMJ Solutions IncUS: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada,…Official notice → - US
Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake…
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- US
Park Avenue Compounding recalls Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint…
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- US
DermaRite Industries, LLC recalls Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c)…
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.