Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Read the official notice →- Date
- 2026-09-16
- Country
- United States
- Brand
- Atrium Medical
- Product
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Atrium Medical recalls
- 2024-10-16
USAtrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice →- 2024-06-12
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Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide including Puerto Rico, and the…Official notice → - 2024-01-03
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Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers.…
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. No foreign distribution.Official notice → - 2023-12-13
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Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
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Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA · DeviceAtrium Medical CorporationUS: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TXOfficial notice → - 2023-11-22
- US
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice →
Other drugs & medical recalls in the United States
- 2026-09-16
- US
Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
FDA · DeviceNipro Renal Soultions USA, CorporationWorldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI,…Official notice → - US
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines)…
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
C.R. Bard Inc recalls Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
FDA · DeviceC.R. Bard IncWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of…
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada and…Official notice → - US
AVID Medical, Inc. recalls Halyard IV Start Kit Non-Sterile REF: KRIV26-02
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Medical Action Industries, Inc. 306 recalls Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride…
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
FDA · DeviceMedical Action Industries, Inc. 306US distribution to states of: IA, VA, MO, KS, FL, OH and LS.Official notice →