The Recall Desk

Hazard

Surgical Risk recalls

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

What the numbers show

Total
51
Critical
0
Severe
3
Most recent
2026-08-12

Of the 51 surgical risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (6%) 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 surgical risk 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 51

  • HighFDA (Devices)·Z-2884-2026·2026-08-12

    USTAR II Knee System Hinge Box Trial Recall

    United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.

    Product
    Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2026·2026-04-08

    da Vinci monopolar curved scissors recalled over frayed grip cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2026·2026-04-08

    da Vinci mega needle driver recalled over broken or frayed cables

    Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2026·2026-04-08

    da Vinci tenaculum forceps recalled over frayed or broken pitch cables

    Intuitive Surgical is recalling da Vinci S and Si Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.

    Product
    Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp end
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2026·2026-04-08

    da Vinci permanent cautery hook recalled over frayed pitch cables

    Intuitive Surgical is recalling da Vinci S and Si Permanent Cautery Hook Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.

    Product
    Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2026·2026-04-08

    da Vinci double fenestrated grasper recalled over broken grip cables

    Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2026·2026-04-08

    da Vinci grasping retractor instruments recalled over broken grip cables

    Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2026·2026-04-08

    VOLT locking screw taps swapped between lots carry incorrect thread

    The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2026·2026-04-08

    VOLT bone taps swapped between lots carry the incorrect thread

    The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2026·2026-04-01

    Erbe flexible cryoprobe 20402-401 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2026·2026-04-01

    Erbe flexible cryoprobe 20402-410 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2026·2026-04-01

    Erbe flexible cryoprobe 20402-411 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2026·2026-04-01

    TECNIS Eyhance intraocular lens haptic may stick to the optic

    AMO Puerto Rico Manufacturing is recalling TECNIS Eyhance IOLs with the TECNIS Simplicity Delivery System because a limited quantity may have a haptic that sticks to the optic, preventing consistent unfolding.

    Product
    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2026·2026-04-01

    Olympus Everest bipolar forceps model 3005 jaws may break

    Olympus is recalling Everest Bipolar Cutting Forceps model 3005 because a supplier did not adequately validate the welding process, and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2026·2026-04-01

    Olympus HALO PKS cutting forceps jaws may break from defective welds

    Olympus is recalling HALO PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2026·2026-04-01

    Orthalign drill plate sizes 1-5 may allow excessive bone cut

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1644-2026·2026-04-01

    Olympus PKS cutting forceps jaws may break from defective welds

    Olympus is recalling PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visuali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2026·2026-04-01

    Olympus PKS cutting forceps 920000PK jaws may break from welds

    Olympus is recalling PKS Cutting Forceps with cord, model 920000PK, because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break.

    Product
    Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2026·2026-04-01

    Orthalign knee drill plates may allow a bone cut exceeding specification

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2026·2026-04-01

    Olympus Everest bipolar cutting forceps jaws may break from defective welds

    Olympus is recalling Everest Bipolar Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2026·2026-04-01

    Olympus PK cutting forceps jaws may break from defective welds

    Olympus is recalling PK Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2026·2026-04-01

    Olympus PKS cutting forceps 3005PK jaws may break from defective welds

    Olympus is recalling PKS Cutting Forceps model 3005PK because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2026·2026-03-25

    Stryker sagittal saw attachment cover screws may loosen and detach

    Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because the external screws securing the cover to the saw housing may loosen and detach during use.

    Product
    MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2026·2026-03-18

    Medline surgical drapes may delaminate prematurely after recommended laundering

    Medline is recalling five surgical drape products because the fabric may delaminate prematurely when the included laundering instructions are followed.

    Product
    Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT
    Category
    Medical Device
    Distribution
    Distributed nationwide