Medical DeviceNov 5, 2025
Cepheid Xpert SA Nasal Complete recall — FDA Z-0414-2026
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class IIFDA: OngoingCepheid
21,444medical device recall records
2,151FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records
Records — page 97
21,444 detailed records are currently available in this category.
Medical DeviceNov 5, 2025
Surgical Theater SyncAR Surgical Navigation Advanced Platform Patient Engagement recall — FDA Z-0322-2026
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…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 recall — FDA Z-0355-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip recall — FDA Z-0334-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter recall — FDA Z-0360-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Vantive US Healthcare Sharesource Connectivity Platform for Use with Homechoice Claria recall — FDA Z-0409-2026
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual…
Class IIFDA: OngoingVantive US Healthcare LLC
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 recall — FDA Z-0335-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0304-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
Siemens Healthcare Diagnostics Assay: IMMULITE 2000 Intact PTH recall — FDA Z-0366-2026
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S recall — FDA Z-0344-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike, 01 units REF: CL-10-10 recall — FDA Z-0328-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Microgenics Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control recall — FDA Z-0415-2026
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient…
Class IIFDA: OngoingMicrogenics Corporation
Medical DeviceNov 5, 2025
IMPRIS Imaging IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet recall — FDA Z-0162-2026
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Class IFDA: OngoingIMPRIS Imaging Inc.
Medical DeviceNov 5, 2025
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros recall — FDA Z-0339-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 recall — FDA Z-0345-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ENDOMAGNETICS Magseed Pro 7 cm soft tissue marker recall — FDA Z-0316-2026
Potential for contamination with cotton fibers.
Class IIFDA: OngoingENDOMAGNETICS LTD
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 recall — FDA Z-0343-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Aesculap SEALING CAP FOR 10/12MM TROCARS recall — FDA Z-0310-2026
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceNov 5, 2025
AESCULAP SEALING UNIT FOR 10/12MM TROCARS recall — FDA Z-0311-2026
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceNov 5, 2025
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0308-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
CareFusion 303 All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 recall — FDA Z-0371-2026
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceNov 5, 2025
CareFusion 303 Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 recall — FDA Z-0367-2026
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceOct 29, 2025
Medline Industries Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item recall — FDA Z-0234-2026
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceOct 29, 2025
SEDECAL SA MobileDiagnost wDR 2.2 recall — FDA Z-0243-2026
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Class IIFDA: OngoingSEDECAL SA
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.