Covidien recalls COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are…
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Covidien
- Product
- COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are…
- Classification
- Class II
- Units
- U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-05-03
USCovidien LP recalls VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
FDA · DeviceCovidien LPWorldwide - US Nationwide distribution in the states of NC and the countries…Official notice →- 2023-04-26
- US
Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF,…
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories.…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of PR, CA, FL,…Official notice → - 2023-04-19
- US
Covidien, LP recalls Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of…
FDA · DeviceCovidien, LPWorldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA,…Official notice → - 2023-03-15
- US
Covidien, LP recalls Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These…
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide distribution in the states of Arkansas,…Official notice → - 2023-03-08
- US
Covidien, LP recalls Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement…
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
FDA · DeviceCovidien, LPUS Distribution to states of: CA, GA, NY and OUS Foreign distribution to…Official notice → - US
Covidien, LP recalls Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11…
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
FDA · DeviceCovidien, LPUS Nationwide Distribution and OUS Foreign distribution to countries of:…Official notice →
Other drugs & medical recalls in the United States
- 2023-04-12
- US
Preferred Pharmaceuticals, Inc. recalls Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge…
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
- US
RemedyRepack Inc. recalls Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only,…
cGMP Deviations
FDA · DrugRemedyRepack Inc.RemedyRepack distributed product to consignees nationwide within the United…Official notice → - US
Azurity Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL…
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- 2023-04-05
- US
Limacorporate S.p.A recalls SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be…
- US
Baxter Healthcare Corporation recalls Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA · DeviceBaxter Healthcare CorporationUS distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.Official notice → - US
Stryker Sustainability Solutions recalls Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder…
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between…
FDA · DeviceStryker Sustainability SolutionsUS: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE,…Official notice →