The Recall Desk

Hazard

Foreign Body recalls

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

What the numbers show

Total
124
Critical
2
Severe
21
Most recent
2026-03-18

Of the 124 foreign body recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (17%) 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 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.

76–100 of 124

  • HighFDA (Devices)·Z-2413-2023·2023-08-23

    HF Resection Electrodes Recalled for Wire Breakage and Patient Fragment Hazard

    Olympus HF Resection Electrodes are being recalled due to reports of loop wire breakage when contacting metal objects. Broken fragments can fall inside the patient and require retrieval.

    Product
    HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2023·2023-05-17

    Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring

    Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.

    Product
    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2023·2023-02-22

    iTotal Identity Impactor Handle surgical screws may loosen during procedures

    Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.

    Product
    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2023·2023-01-25

    Vasoshield Syringe Ink Chips May Cause Embolic Events

    Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.

    Product
    Hemopro 2 with Vasoshield, Model VH-4001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2023·2023-01-18

    Philips Fetal Spiral Electrode may break off during labor monitoring

    Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.

    Product
    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2022·2022-02-16

    Universal Chuck Surgical Instrument Handle May Detach and Release Ball Bearings

    The Universal Chuck instrument handle may loosen and release ball bearings onto the surgical field. If not recovered, these bearings could delay surgery and potentially cause infection or tissue damage.

    Product
    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2022·2022-02-09

    Chameleon PTA Balloon Catheter difficult protector sleeve removal risk

    The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.

    Product
    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2021·2021-09-08

    Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns

    Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.

    Product
    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2021·2021-06-30

    novaplus General Purpose Kit hemostats recalled for potential metal flaking

    Medical Action Industries is recalling novaplus General Purpose Kit (Cat. No. 56603) containing hemostats that may have flaking metal and brown spots on the instruments.

    Product
    novaplus, General Purpose Kit, Cat. No. 56603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2020·2020-05-20

    Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing

    Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.

    Product
    EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2020·2020-04-15

    AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect

    AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.

    Product
    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0598-2020·2019-12-11

    Allergan Recalls XEN Gel Stent Due to Residual Polishing Compounds

    Allergan is recalling XEN Gel Stent implants because residual polishing compounds on the injector needle may transfer to the patient's eye, causing irritation or inflammation.

    Product
    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk

    Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3024-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

    Intuitive Surgical is recalling 23,064 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors because cracks in the extension tube may cause plastic fragments to fall into patients.

    Product
    da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3025-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk

    Intuitive Surgical is recalling 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors because cracks may form in the extension tube, potentially causing fragments to fall into patients.

    Product
    da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2018·2018-03-07

    Olympus Recalls Urologic Endoscopic Working Inserts and Bridges Due to Adhesive Fragments

    Olympus is recalling specific urologic endoscopic working inserts and bridges because adhesive fragments may detach and enter patients during procedures.

    Product
    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage

    Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2017·2017-05-24

    Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.

    Product
    GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.

    Product
    OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states