The Recall Desk

Hazard

Implant recalls

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

What the numbers show

Total
74
Critical
3
Severe
0
Most recent
2026-06-24

Of the 74 implant recalls we have scored against our rubric, 3 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 implant 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.

51–74 of 74

  • CriticalFDA (Devices)·Z-0043-2026·2025-10-22

    Thoracic endovascular grafts recalled over coating scrapings that may embolize

    Cook Medical is recalling 695 Zenith Alpha 2 Thoracic Endovascular Grafts because affected devices may contain PTFE coating scrapings that could be released during deployment.

    Product
    Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-1
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0148-2026·2025-10-22

    Metal and ceramic femoral heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 cobalt chromium and ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2026·2025-10-22

    Femoral head implants recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    Product
    BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0151-2026·2025-10-22

    Ceramic femoral heads recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    Product
    BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0152-2026·2025-10-22

    Ceramic endo modular heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 ceramic Endo Modular Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CER
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0150-2026·2025-10-22

    Bipolar femoral heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 bipolar heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BI
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

    MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.

    Product
    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2026·2025-10-22

    CX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2026·2025-10-22

    Uni-polar endo heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 metal uni-polar Endo Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 E
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2026·2025-10-22

    CX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2026·2025-10-22

    TENACIO pumps without InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling TENACIO Pump without InhibiZone, UPN 72404420, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump without InhibiZone; UPN: 72404420;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO pumps with InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2026·2025-10-15

    Scleral reinforcement matrix recalled after complaints of early patch exposure

    CorNeat Vision is recalling 180 EverPatch+ units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

    Product
    EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2026·2025-10-15

    Ocular surgical matrix recalled after complaints of early patch exposure

    CorNeat Vision is recalling 630 CorNeat EverPatch units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

    Product
    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2026·2025-10-08

    Dental implants recalled after import under non compliant temperature and storage conditions

    S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.

    Product
    IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2025·2025-09-03

    Limb salvage stem extensions recalled after unidentified substance found on devices

    ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2025·2025-09-03

    Canal filling stems recalled after unidentified substance found during retrospective evaluation

    ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2025·2025-09-03

    Limb salvage canal filling stems recalled after unidentified substance found on devices

    ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2025·2025-07-09

    Apex Knee System components recalled over loss of sterile packaging integrity

    Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.

    Product
    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
    Category
    Medical Device
    Distribution
    Distributed nationwide