BioPro, Inc.
Complete recall history across all FDA and CPSC categories — 37 total recalls
BioPro, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (37)
FDA medical device enforcement actions by BioPro, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 9, 2025 | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Sep 9, 2025 | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Sep 9, 2025 | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Sep 9, 2025 | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Sep 9, 2025 | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Sep 9, 2025 | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131... | Potential packaging issue that could compromise the sterile barrier. Defect m... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | There is an incorrect statement regarding MR Compatibility in the BioPro Tita... | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accesso... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioP... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the Bi... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the Bi... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accesso... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the Bi... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Access... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accesso... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the Bio... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accesso... | Manufacturing flaw in the sterile barrier system | Class II |
| Jun 25, 2019 | Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the Bi... | Manufacturing flaw in the sterile barrier system | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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