The Recall Desk

Hazard

Tissue Damage recalls

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

What the numbers show

Total
73
Critical
4
Severe
23
Most recent
2024-11-27

Of the 73 tissue damage recalls we have scored against our rubric, 4 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (32%) 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 tissue damage 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.

51–73 of 73

  • HighFDA (Devices)·Z-2158-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.

    Product
    Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2161-2020·2020-06-03

    Applied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.

    Product
    Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2159-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.

    Product
    Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
    Category
    Medical Device
    Distribution
    43 states
  • 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-0419-2020·2019-11-27

    Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.

    Product
    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2020·2019-11-27

    Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.

    Product
    Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2018·2018-03-28

    Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect

    Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.

    Product
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2017·2017-08-02

    Invuity PhotonBlade Recalled for Potential Unintended Energy Discharge

    Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.

    Product
    INVUITY(R) PhotonBlade(TM), REF PB1
    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-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-2212-2016·2016-08-03

    BD Recalls Diamond-Flex Retractors Due to Weld Failure Risk

    BD is recalling specific Diamond-Flex Circular Retractors because a weld failure could cause wire protrusion, potentially damaging tissue or organs during use.

    Product
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0205-2016·2015-11-11

    ConMed Recalls Arthroscopic Energy 50 Probe Due to Programming Error

    ConMed is recalling 276 Arthroscopic Energy 50 Probes with Suction because a programming error may generate excess heat, increasing the risk of tissue damage during surgery.

    Product
    Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2770-2015·2015-09-23

    Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation

    Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.

    Product
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1371-2015·2015-04-08

    Edwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas

    Edwards Lifesciences is recalling specific sizes of the Fem-Flex II Pediatric Femoral Arterial Cannula due to a protruding wire at the tip that could cause tissue damage.

    Product
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2015·2015-02-11

    Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture

    Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.

    Product
    Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2015·2015-01-14

    Synthes Small Electric Drive Recalled for Unintended Start and Malfunction

    Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.

    Product
    Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2013·2013-09-25

    Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification

    Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.

    Product
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2062-2012·2012-08-22

    Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk

    Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.

    Product
    Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2064-2012·2012-08-22

    Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.

    Product
    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2061-2012·2012-08-22

    Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality

    Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.

    Product
    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2063-2012·2012-08-22

    Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.

    Product
    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide