CooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers:…
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment…
Read the official notice →- Date
- 2026-09-30
- Country
- United States
- Brand
- CooperSurgical
- Product
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers:…
- Classification
- Class I
- Units
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 CooperSurgical recalls
- 2025-07-30
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The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
FDA · DeviceCooperSurgical, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →- 2024-12-25
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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An…
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
FDA · DeviceCooperSurgical, Inc.States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below,…Official notice → - 2024-10-02
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During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - 2024-02-21
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FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - 2024-02-14
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CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard,…
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Other drugs & medical recalls in the United States
- 2026-09-30
- US
Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610…
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries,…
FDA · DeviceHeidelberg Engineering GmbHWorldwide - US Nationwide distribution in the state of Massachusetts and the…Official notice → - US
Boston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and territories of Puerto Rico and the countries of…Official notice → - US
AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
- US
- US
Amneal Pharmaceuticals of New York, LLC recalls Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use…
Defective Delivery System: Possibility of no medication in the prefilled pen.
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