Recall Register

Food, drugs, devices › Firms

BioPro, Inc.

FDA recalling firm · 3 enforcement events · 37 product records · 2019–2025 · MI

BioPro, Inc. has 3 FDA enforcement events on this register (37 product records) between 2019 and 2025: 3 device; the busiest year was 2019 with 1.

0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in MI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
9 Sep 2025BioPro 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 FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053…DeviceClass II6Ongoing
1 Feb 2022Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813DeviceClass II10Terminated
25 Jun 2019K-Wire HBS Sterile, Item Number 19688 - 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.DeviceClass II21Terminated

By type and class

Device3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

19
20
21
22
23
24
25
26
Enforcement events for BioPro, Inc. by year initiated.

Questions and answers

How many FDA recalls has BioPro, Inc. had?

3 enforcement events (37 product records) on this register, 2019–2025: 3 device.

Are any BioPro, Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are BioPro, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.