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.
Read the official notice →- Date
- 2024-04-10
- Country
- United States
- Brand
- Covidien
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-05-08
USCovidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
FDA · DeviceCovidienUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI…Official notice →- US
Covidien, LP recalls Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk…
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound…
FDA · DeviceCovidien, LPInternational distribution in the countries of Portugal and Italy.Official notice → - 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 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 → - 2024-03-27
- US
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…
FDA · DeviceCovidienUS Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL,…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 →
Other drugs & medical recalls in the United States
- 2024-04-10
- US
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis…
FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice → - US
3M Company - Health Care Business recalls 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x…
Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to…
FDA · Device3M Company - Health Care BusinessWorldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - US
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Inadequate reprocessing validation evidence
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in…
- US
Agfa N.V. recalls Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube,…
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is…
FDA · DeviceAgfa N.V.Worldwide distribution - US Nationwide and the countries of Canada, Argentina,…Official notice → - US
O&M HALYARD, INC. recalls HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
FDA · DeviceO&M HALYARD, INC.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice →