The Recall Desk

Hazard

Retained Foreign Body recalls

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

What the numbers show

Total
17
Critical
0
Severe
10
Most recent
2026-07-15

Of the 17 retained foreign body recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (59%) 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 retained foreign body 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.

1–17 of 17

  • SevereFDA (Devices)·Z-2710-2026·2026-07-15

    Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled

    Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.

    Product
    Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2712-2026·2026-07-15

    Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk

    Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.

    Product
    Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2025·2025-09-10

    Sterile cover kits recalled because elastic bands may detach during surgery

    Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.

    Product
    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0940-2024·2024-02-07

    Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures

    Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.

    Product
    EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2024·2024-02-07

    Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies

    Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.

    Product
    EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2023·2022-11-23

    Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use

    Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.

    Product
    Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2022·2022-06-15

    Surgical needle electrode tip detachment risk during gastroenterology procedures

    ROi CPS LLC is recalling a sterile surgical needle used in gastroenterology bypass procedures because the electrode tip may detach during use. The recall affects 125 units distributed in North Carolina.

    Product
    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0702-2022·2022-03-09

    da Vinci Surgical Cannula Reducer Metal Tip May Dislodge During Surgery

    Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.

    Product
    da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2021·2021-01-13

    Medline Aortic Graft Kits Recalled for Non-Detectable Sponge Component

    Medline Industries is recalling 45 aortic graft kits in Canada because the included sponge is not x-ray detectable.

    Product
    Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0781-2021·2021-01-13

    Medline Thyroid Pack Recall Due to Non-X-Ray Detectable Sponge

    Medline Industries is recalling 40 Thyroid Pack CKHA-LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only to Canada.

    Product
    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2768-2020·2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.

    Product
    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidew
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0168-2020·2019-10-30

    Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk

    Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.

    Product
    Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1236-2018·2018-04-04

    Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing

    Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.

    Product
    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2483-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2482-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide