The Recall Desk

Manufacturer

BioPro, Inc.

37 recalls in our database name BioPro, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
37
Critical
0
Severe
0
Most recent
2025-10-22

Of the 37 recalls from BioPro, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 37

  • 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-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-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-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-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-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-0686-2022·2022-03-09

    Titanium Toe Implants Recalled for Incorrect MRI Safety Labeling

    BioPro Titanium MPJ toe implants are recalled because labeling incorrectly claims MRI safety without actual testing. Patients should consult their physician before undergoing MRI procedures.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2022·2022-03-09

    Titanium Toe Joint Implant Contains False MR Compatibility Claims

    BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2022·2022-03-09

    BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Statements

    BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2022·2022-03-09

    Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims

    BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error

    BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2022·2022-03-09

    Titanium MPJ Toe Implant Recalled for Incorrect MR Safety Labeling

    BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x34 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x105 (Item 19669) due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2019·2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x95 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.

    Product
    Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x90 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.6x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide