The Recall Desk

Hazard

Device Breakage recalls

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

What the numbers show

Total
156
Critical
1
Severe
41
Most recent
2026-08-12

Of the 156 device breakage recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 41 (26%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device 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.

1–25 of 156

  • HighFDA (Devices)·Z-2904-2026·2026-08-12

    Tissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall

    Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2902-2026·2026-08-12

    Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2903-2026·2026-08-12

    Tissium Peripheral Nerve Repair Device Shelf Life Recall

    Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2558-2026·2026-07-01

    Surgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk

    Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.

    Product
    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2026·2026-07-01

    Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage

    Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2026·2026-07-01

    Surgify Halo surgical drill equipment recalled for potential burr breakage

    Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.

    Product
    Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2026·2026-07-01

    Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery

    Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2026·2026-07-01

    Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall

    Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid Left 4-Peg Augment Reamer Guide because the plastic guides can catch during reaming and break. Five complaints have been received.

    Product
    Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2026·2026-07-01

    Surgify Halo Surgical Burr Recalled for Breakage Risk

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2026·2026-07-01

    Surgify Halo Surgical Burr May Break During Spinal Surgery

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2026·2026-07-01

    Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage

    Zimmer is recalling the Off-Axis Alliance Glenoid Right 4-Peg Augment Reamer Guide (Model 110040476) after five complaints that plastic guides broke during reaming.

    Product
    Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2026·2026-07-01

    Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall

    Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System reamer guides (Model 110040242) due to plastic guides that can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2527-2026·2026-07-01

    Zimmer Shoulder System Reamer Guide recalled for plastic breakage

    Zimmer is recalling the Off-Axis Comprehensive Shoulder System Small Reamer Guide due to plastic guides catching and breaking during reaming procedures.

    Product
    Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1945-2026·2026-05-06

    Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage

    Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.

    Product
    Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device desig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2026·2026-04-08

    Artoura textured tissue expander infusion set needles may be blunt

    Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.

    Product
    Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2026·2026-04-08

    CPX 4 medium height tissue expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth medium height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2026·2026-04-08

    CPX 4 SILTEX low height expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2026·2026-04-08

    Artoura breast tissue expander infusion set needles may be blunt

    Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.

    Product
    Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2026·2026-04-08

    Jiffy composite polisher cups may crumble and break apart easily

    Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.

    Product
    Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1687-2026·2026-04-08

    Artoura ultra high profile expander infusion needles may be blunt

    Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.

    Product
    Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2026·2026-04-08

    CPX 4 low height tissue expander infusion needles may be blunt

    Mentor is recalling the CPX 4 US Breast Tissue Expander with Suture Tabs, smooth low height 650 cc, because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2026·2026-04-08

    CPX 4 tall height tissue expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2026·2026-03-11

    B. Braun 21G 4.4 cm winged infusion needles may break

    B. Braun Medical is recalling 21G x 4.4 cm Winged Infusion devices, model 7B3050, because the needle tip may be dull or blunt, difficult to advance, or may break.

    Product
    Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2026·2026-03-11

    B. Braun 21GA winged infusion sets may have blunt needle tips

    B. Braun Medical is recalling 21GA Winged Infusion Sets, model 7M2802, because the needle tip may be dull or blunt, difficult to advance, or may break.

    Product
    Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2026·2026-03-11

    B. Braun 21GA winged infusion single packs may have blunt needles

    B. Braun Medical is recalling 21GA Winged Infusion single packs, model 7A3842, because the needle tip may be dull or blunt, difficult to advance, or may break.

    Product
    Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneou
    Category
    Medical Device
    Distribution
    Distributed nationwide