Pro Med Instruments recalls
Pro Med Instruments appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2025-06-04.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2017-12-13 to 2025-06-04 |
| By agency | FDA Device (5) |
| By classification | Class I (3), Class II (2) |
| By status | terminated (4), ongoing (1) |
| Distribution named in notices | CA, GA, MS, OH, TN, TX, US, WV |
Recalls
- DORO¿ Easy-Connect Navigation Adaptor
FDA Device · Class II · 2025-06-04 · Pro Med Instruments
Reason: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded. - DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments
Reason: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. - DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments
Reason: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. - DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal su…
FDA Device · Class I · 2018-09-26 · Pro Med Instruments
Reason: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. - pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY T…
FDA Device · Class II · 2017-12-13 · Pro Med Instruments
Reason: The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.