The Recall Desk

Hazard

Suture Breakage recalls

22 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
22
Critical
0
Severe
2
Most recent
2026-02-04

Of the 22 suture breakage recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (9%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all suture breakage recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–22 of 22

  • HighFDA (Devices)·Z-1168-2026·2026-02-04

    Screw-in suture anchors recalled after reports of breakage and bending

    Aju Pharm is recalling 600 units of the Genesis Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Genesis Screw-In Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0437-2026·2026-02-04

    Genesis knotless anchors recalled after reports of device failure

    Aju Pharm is recalling 1,163 units of the Genesis Knotless Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Goldenroot Lemon Ginger Hibiscus Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32821 4. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1207-2026·2026-02-04

    Dual thread screw-in anchors recalled after reports of device failure

    Aju Pharm is recalling 400 units of the Genesis Dual Thread Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2026·2026-02-04

    AlternatiV+ screw-in anchors recalled after reports of device failure

    Aju Pharm is recalling 416 units of the AlternatiV+ Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    AlternatiV+ Screw-In Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2026·2026-02-04

    Push-in suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 200 units of the Genesis Push-In Suture Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Genesis Push-In Suture Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2026·2026-02-04

    Biocomposite suture anchors recalled after reports of breakage and bending

    Aju Pharm is recalling 1,088 units of the Fixone Biocomposite Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Fixone Biocomposite Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2026·2026-02-04

    Hybrid suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2026·2026-02-04

    Knotless suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 2,569 AlternatiV+ Max Knotless Anchors after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    AlternatiV+ Max Knotless Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2023·2023-05-17

    PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use

    Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.

    Product
    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1101-2023·2023-02-15

    RipCord Syndesmosis Button suture may break during orthopedic surgery

    The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.

    Product
    RipCord Syndesmosis Button, REF: STA001K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2020·2019-10-16

    Aziyo BioEnvelope Surgical Mesh Recalled for Possible Suture Brittleness

    Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.

    Product
    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Larg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2020·2019-10-16

    AZIYO BIOLOGICS Recalls CanGaroo Envelopes Due to Suture Brittleness

    AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.

    Product
    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Env
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2018·2018-05-16

    Boston Scientific Recalls Pinnacle Posterior PFR Kits Due to Suture Breakage Risk

    Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.

    Product
    PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1623-2018·2018-05-16

    Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk

    Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.

    Product
    Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1621-2018·2018-05-16

    Boston Scientific Recalls Capio RP Sutures Due to Breakage Risk

    Boston Scientific is recalling 2,567 units of Capio RP sutures because they may break or detach during surgery.

    Product
    Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1622-2018·2018-05-16

    Boston Scientific Recalls Uphold LITE Pelvic Organ Prolapse Mesh Devices

    Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.

    Product
    Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1620-2018·2018-05-16

    Boston Scientific Recalls Capio Sutures Due to Breakage Risk

    Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.

    Product
    Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1618-2018·2018-05-16

    Boston Scientific Recalls Capio CL Sutures Due to Breakage Risk

    Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.

    Product
    Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1617-2018·2018-05-16

    Boston Scientific Recalls Capio SLIM Box 5 Sutures Due to Breakage Risk

    Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.

    Product
    Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1626-2018·2018-05-16

    Boston Scientific Recalls Uphold Vaginal Support System Due to Suture Breakage

    Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.

    Product
    Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1616-2018·2018-05-16

    Boston Scientific Recalls Capio SLIM Suture Capturing Device Due to Breakage Risk

    Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.

    Product
    Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1619-2018·2018-05-16

    Boston Scientific Recalls Capio Open Access Box 4 Sutures

    Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.

    Product
    Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state