BioPro, Inc. recall records

6 reported ongoing

16 records in this archive. Latest source date Sep 9, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 28...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Descript...
FDA device enforcement

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 ...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO ...
FDA device enforcement

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 ...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 ...
FDA device enforcement

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 H...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM ...
FDA device enforcement

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 M...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MOD...
FDA device enforcement

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 ...

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIReported ongoing

Distribution: US Domestic distribution to Texas and Michigan.

Official source for BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD L...
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
FDA device enforcement

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
FDA device enforcement

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
FDA device enforcement

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the ...

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Official source for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

Reasons in these listed records

  • Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
  • There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and i...

These examples come from this result page and are not a ranking of every recall reason.

Checking BioPro, Inc.

Is there a recall on biopro, inc. right now?

This archive contains 16 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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