Covidien recalls Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to…
Read the official notice →- Date
- 2024-03-27
- Country
- United States
- Brand
- Covidien
- Product
- Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Covidien recalls
- 2024-05-01
US
Covidien LP recalls Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and…
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →- 2024-04-10
US
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →US
Covidien, LP recalls Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully…
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of France, Hong Kong,…Official notice →- 2024-02-14
US
Covidien LP recalls AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in…
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
FDA · DeviceCovidien LPUS Nationwide distribution in the states of CA, CO, FL, IL, TX.Official notice →- 2024-02-07
US
Covidien LP recalls Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound…
FDA · DeviceCovidien LPWorldwide US Nationwide distribution including in the states of AL, AZ, CA,…Official notice →- 2024-01-10
US
Covidien recalls Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
FDA · DeviceCovidienWorldwide distribution - US: Nationwide and surrounding territories.Official notice →
Other drugs & medical recalls in the United States
- 2024-03-27
US
Landauer recalls microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000,…
Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical…
FDA · DeviceLandauerWorldwide distribution - United States Nationwide and the countries of…Official notice →US
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the…
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ,…Official notice →US
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
FDA · DeviceD.O.R.C. Dutch Opthalmic Research Center Intl B.V.US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH,…Official notice →US
Baxter Healthcare Corporation recalls HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Florida.Official notice →US
Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample…
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
US
Thommen Medical AG recalls impression coping, repositionable, short, screw-retained, PF 4.0
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
FDA · DeviceThommen Medical AGUS Nationwide distribution in the states of OH and KY.Official notice →