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Spes Medica FDA Recalls

5 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE50Class IIApr 8, 2021The supplier informed them of possible deviations of the par
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological moClass IIApr 8, 2021The supplier informed them of possible deviations of the par
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesClass IIApr 8, 2021The supplier informed them of possible deviations of the par
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesClass IIApr 8, 2021The supplier informed them of possible deviations of the par
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DClass IIApr 8, 2021The supplier informed them of possible deviations of the par

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