Reason: Due to out of the box wobble of the driver.
Distributed: U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United KingdomReason: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Distributed: US Nationwide.Reason: Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Distributed: US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.Reason: Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
Distributed: US Nationwide distribution tin the states of CA, FL, IA, and TX.Reason: An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
Distributed: US: AZ, CAReason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distributed: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distributed: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distributed: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distributed: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distributed: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.