Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: CONSTRUX" Mini PTC Spacer System
Product Name: CONSTRUX" Mini PTC Spacer System
Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel;
37-3107SP 12mm W X 12mm L, 7mm H, Parallel;
37-3108SP 12mm W X 12mm L, 8mm H, Parallel;
37-3109SP 12mm W X 12mm L, 9mm H, Parallel;
37-3110SP 12mm W X 12mm L, 10mm H, Parallel;
37-3111SP 12mm W X 12mm L, 11mm H, Parallel;
37-3112SP 12mm W X 12mm L, 12mm H, Parallel;
37-3113SP 12mm W X 12mm LW, 13mm H, Parallel;
37-3114SP 12mm W X 12mm WL, 14mm H, Parallel;
37-3006SP 12mm W X 12mm L, 6mm H, 5 Lordotic;
37-3007SP 12mm W X 12mm L, 7mm H, 5 Lordotic;
37-3008SP 12mm W X 12mm L, 8mm H, 5 Lordotic;
37-3009SP 12mm WL X 12mm L, 9mm H, 5 Lordotic;
37-3010SP 12mm W X 12mm L, 10mm H, 5 Lordotic;
37-3011SP 12mm W X 12mm L, 11mm H, 5 Lordotic;
37-3012SP 12mm W X 12mm L, 12mm H, 5 Lordotic;
37-3013SP 12mm W X 12mm L, 13mm H, 5 Lordotic;
37-3014SP 12mm W X 12mm L, 14mm H, 5 Lordotic;
37-3207SP 12mm W X 12mm L, 7mm H, 10 Lordotic;
37-3208SP 12mm W X 12mm L, 8mm H, 10 Lordotic;
37-3209SP 12mm W X 12mm L, 9mm H, 10 Lordotic;
37-3210SP 12mm W X 12mm L, 10mm H, 10 Lordotic;
37-3211SP 12mm W X 12mm L, 11mm H, 10 Lordotic;
37-3212SP 12mm W X 12mm L, 12mm H, 10 Lordotic;
37-4106SP 15mm W X 12mm L, 6mm H, Parallel;
37-4107SP 15mm W X 12mm L, 7mm H, Parallel;
37-4108SP 15mm W X 12mm L, 8mm H, Parallel;
37-4109SP 15mm W X 12mm L, 9mm H, Parallel;
37-4110SP 15mm W X 12mm L, 10mm H, Parallel;
37-4111SP 15mm W X 12mm L, 11mm H, Parallel;
37-4112SP 15mm W X 12mm L, 12mm H, Parallel;
37-4113SP 15mm W X 12mm L, 13mm H, Parallel;
37-4114SP 15mm W X 12mm L, 14mm H, Parallel;
37-4006SP 15mm W X 12mm L, 6mm H, 5 Lordotic;
37-4007SP 15mm W X 12mm L, 7mm H, 5 Lordotic;
37-4008SP 15mm W X 12mm L, 8mm H, 5 Lordotic;
37-4009SP 15mm W X 12mm L, 9mm H, 5 Lordotic;
37-4010SP 15mm W X 12mm L, 10mm H, 5 Lordotic;
37-4011SP 15mm W X 12mm L, 11mm H, 5 Lordotic;
37-4012SP 15mm W X 12mm L, 12mm H, 5 Lordotic;
37-4013SP 15mm W X 12mm L, 13mm H, 5 Lordotic;
37-4014SP 15mm W X 12mm L, 14mm H, 5 Lordotic;
37-4207SP 15mm W X 12mm L, 7mm H, 10 Lordotic;
37-4208SP 15mm W X 12mm L, 8mm H, 10 Lordotic;
37-4209SP 15mm W X 12mm L, 9mm H, 10 Lordotic;
37-4210SP 15mm W X 12mm L, 10mm H, 10 Lordotic;
37-4211SP 15mm W X 12mm L, 11mm H, 10 Lordotic;
37-4212SP 15mm W X 12mm L, 12mm H, 10 Lordotic;
37-5106SP 15mm W X 15mm L, 6mm H, Parallel;
37-5107SP 15mm W X 15mm L, 7mm H, Parallel
37-5108SP 15mm W X 15mm L, 8mm H, Parallel;
37-5109SP 15mm W X 15mm L, 9mm H, Parallel;
37-5110SP 15mm W X 15mm L, 10mm H, Parallel;
37-5111SP 15mm W X 15mm L, 11mm H, Parallel;
37-5112SP 15mm W X 15mm L, 12mm H, Parallel;
37-5113SP 15mm W X 15mm L, 13mm H, Parallel;
37-5114SP 15mm W X 15mm L, 14mm H, Parallel;
37-5006SP 15mm W X 15mm L, 6mm H, 5 Lordotic;
37-5007SP 15mm W X 15mm L, 7mm H, 5 Lordotic;
37-5008SP 15mm W X 15mm L, 8mm H, 5 Lordotic;
37-5009SP 15mm W X 15mm L, 9mm H, 5 Lordotic;
37-5010SP 15mm W X 15mm L, 10mm H, 5 Lordotic;
37-5011SP 15mm W X 15mm L, 11mm H, 5 Lordotic;
37-5012SP 15mm W X 15mm L, 12mm H, 5 Lordotic;
37-5013SP 15mm W X 15mm L, 13mm H, 5 Lordotic;
37-5014SP 15mm W X 15mm L, 14mm H, 5 Lordotic;
37-5207SP 15mm W X 15mm L, 7mm H, 10 Lordotic;
37-5208SP 15mm W X 15mm L, 8mm H, 10 Lordotic;
37-5209SP 15mm W X 15mm LW, 9mm H, 10 Lordotic;
37-5210SP 15mm W X 15mm L, 10mm H, 10 Lordotic;
37-5211SP 15mm W X 15mm L, 11mm H, 10 Lordotic;
37-5212SP 15mm W X 15mm L, 12mm H, 10 Lordotic;
Reason: Labeling contains claims that are not consistently present.
Root cause: Device Design
Recalling firm: Orthofix U.S. LLCType: Intervertebral Fusion Device With Bone Graft, CervicalDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.Recall #Z-0891-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: FORZA" PTC Spacer System
Product Name: FORZA" PTC Spacer System
Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H
38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H;
38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H;
38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H;
38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H;
38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H;
38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H;
38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H;
38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H;
38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H;
38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H;
38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H;
38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H;
38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H;
38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H;
38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H;
38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H;
38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H;
38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H;
38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H;
38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H;
38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H;
38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H;
38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H;
38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H;
38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H;
38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H;
38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H;
38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H;
38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H;
38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H;
38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H;
38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H;
38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H;
38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H;
38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H;
38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H;
38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H;
38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H;
38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H;
38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H;
38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H;
38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H;
38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H;
38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H;
38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H;
38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H;
38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H;
38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H;
38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H;
38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H;
38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H;
38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H;
38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H;
38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H;
38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H;
38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H;
38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H;
38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H;
38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H;
38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H;
38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H;
38-6014SP FORZA PTC Spacer,
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: Pillar" SA PTC Spacer System
Product Name: Pillar" SA PTC Spacer System
Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT;
39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT;
39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT;
39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT;
39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT;
39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT;
39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT;
39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT;
39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT;
39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT;
39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT;
39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT;
39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT;
39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT;
39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT;
39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT;
Reason: Labeling contains claims that are not consistently present.
Root cause: Device Design
Recalling firm: Orthofix U.S. LLCType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.Recall #Z-0893-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: FIREBIRD" SI Fusion System
Product Name: FIREBIRD" SI Fusion System
Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw;
18-1030SP 11mm X 30mm FIREBIRD SI Screw;
18-1035SP 11mm X 35mm FIREBIRD SI Screw;
18-1040SP 11mm X 40mm FIREBIRD SI Screw;
18-1045SP 11mm X 45mm FIREBIRD SI Screw;
18-1050SP 11mm X 50mm FIREBIRD SI Screw;
18-1055SP 11mm X 55mm FIREBIRD SI Screw;
18-1060SP 11mm X 60mm FIREBIRD SI Screw;
18-1065SP 11mm X 65mm FIREBIRD SI Screw;
18-1070SP 11mm X 70mm FIREBIRD SI Screw;
18-2025SP 12mm X 25mm FIREBIRD SI Screw;
18-2030SP 12mm X 30mm FIREBIRD SI Screw;
18-2035SP 12mm X 35mm FIREBIRD SI Screw;
18-2040SP 12mm X 40mm FIREBIRD SI Screw;
18-2045SP 12mm X 45mm FIREBIRD SI Screw;
18-2050SP 12mm X 50mm FIREBIRD SI Screw;
18-2055SP 12mm X 55mm FIREBIRD SI Screw;
18-2060SP 12mm X 60mm FIREBIRD SI Screw;
18-2065SP 12mm X 65mm FIREBIRD SI Screw;
18-2070SP 12mm X 70mm FIREBIRD SI Screw
Reason: Labeling contains claims that are not consistently present.
Root cause: Device Design
Recalling firm: Orthofix U.S. LLCType: Sacroiliac Joint FixationDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.Recall #Z-0894-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: Forza" Ti Spacer System
Product Name: Forza" Ti Spacer System
Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H;
38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H;
38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H;
38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H;
38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H;
38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H;
38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H;
38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H;
38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H;
38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H;
38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H;
38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H;
38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H;
38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H;
38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H;
38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H;
38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H;
38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H;
38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H;
38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H;
38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H;
38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H;
38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H;
38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H;
38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H;
38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H;
38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H;
38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H;
38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H;
38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H;
38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H;
38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H;
38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H;
38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H;
38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H;
38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H;
38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H;
38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H;
38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H;
38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H;
38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H;
38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H;
38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H;
38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H;
38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H;
38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H;
38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H;
38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H;
38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H;
38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H;
38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H;
38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H;
38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H;
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 3, 2025
Brand Name: CONSTRUX" Mini Ti Spacer System
Product Name: CONSTRUX" Mini Ti Spacer System
Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic
37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic
37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic
37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic
37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic
37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic
37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic
37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic
37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic
37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic
37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic
37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic
37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic
37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic
37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic
37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic
37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic
37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic
37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic
37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic
37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic
37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic
37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic
37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic
37-6105SP 12mm W X 12mm L, 5mm H, Parallel
37-6105SP 12mm W X 12mm L, 5mm H, Parallel
37-6105SP 12mm W X 12mm L, 5mm H, Parallel
37-6106SP 12mm W X 12mm L 6mm H, Parallel
37-6106SP 12mm W X 12mm L 6mm H, Parallel
37-6106SP 12mm W X 12mm L 6mm H, Parallel
37-6107SP 12mm W X 12mm L, 7mm H, Parallel
37-6107SP 12mm W X 12mm L, 7mm H, Parallel
37-6107SP 12mm W X 12mm L, 7mm H, Parallel
37-6108SP 12mm W X 12mm L, 8mm H, Parallel
37-6108SP 12mm W X 12mm L, 8mm H, Parallel
37-6108SP 12mm W X 12mm L, 8mm H, Parallel
37-6109SP 12mm W X 12mm L, 9mm H, Parallel
37-6109SP 12mm W X 12mm L, 9mm H, Parallel
37-6109SP 12mm W X 12mm L, 9mm H, Parallel
37-6110SP 12mm W X 12mm L, 10mm H, Parallel
37-6110SP 12mm W X 12mm L, 10mm H, Parallel
37-6110SP 12mm W X 12mm L, 10mm H, Parallel
37-6111SP 12mm W X 12mm L, 11mm H, Parallel
37-6111SP 12mm W X 12mm L, 11mm H, Parallel
37-6111SP 12mm W X 12mm L, 11mm H, Parallel
37-6112SP 12mm W X 12mm L, 12mm H, Parallel
37-6112SP 12mm W X 12mm L, 12mm H, Parallel
37-6112SP 12mm W X 12mm L, 12mm H, Parallel
37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic
37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic
37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic
37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic
37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic
37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic
37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic
37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic
37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic
37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic
37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic
37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic
37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic
37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic
37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic
37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic
37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic
37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 12, 2025
ChemoPlus gowns:
Product Code Product Description
CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile;
CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile;
CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue,
Non-sterile;
CT5504T ChemoPlus Full Coverage Gown,
Closed Back, Extra Large, Medium Blue, Non-sterile;
CT5505T ChemoPlus Full Coverage Gown,
Closed Back, Extra Extra Large, Medium Blue, Non-sterile;
DP5001GT ChemoPlus Full Coverage Gown,
Open Back, Large, medium Blue, Non- sterile;
DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue,
Non-sterile;
DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue,
Non-sterile;
DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile;
CT5500TS ChemoPlus Full Coverage Sleeve,
Universal, Medium Blue, Sterile;
CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium
Blue, Non-sterile;
CT5503TS ChemoPlus Full Coverage Gown,
Closed Back, Large, Medium Blue, Sterile;
CT5504TS ChemoPlus Full Coverage Gown,
Closed Back, Extra Large, Medium Blue, Sterile;
CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large,
Medium Blue, Sterile;
Reason: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Root cause: Under Investigation by firm
Recalling firm: Cardinal Health 200, LLCType: Gown, SurgicalDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-0897-2026 Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0898-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0899-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0900-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0901-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0902-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0903-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Root cause: Package design/selection
Recalling firm: Medline Industries, LPType: Tape And Bandage, AdhesiveDistribution: US, Guam, Canada, United Arab EmiratesRecall #Z-0904-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 6, 2025
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit
REF 787614
Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Stent, UreteralDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).Recall #Z-0905-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 6, 2025
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit
REF 788426
Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Stent, UreteralDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).Recall #Z-0906-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 6, 2025
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit
REF 788630
Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Stent, UreteralDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).Recall #Z-0907-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 6, 2025
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit
REF 78826
Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Stent, UreteralDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).Recall #Z-0908-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 19, 2025
AMSCO 7052HP Washer/Disinfector
Model/Catalog Number: 7052HP
Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
Reason: Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Root cause: Process control
Recalling firm: Steris CorporationType: Disinfector, Medical DevicesDistribution: Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.Recall #Z-0909-2026 Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 19, 2025
AMSCO 7053HP Washer/Disinfector
Model/Catalog Number: 7053HP
Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
Reason: Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Root cause: Process control
Recalling firm: Steris CorporationType: Disinfector, Medical DevicesDistribution: Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.Recall #Z-0910-2026