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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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Recall
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FDA Recall
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Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370... 3 03/09/2026 FEI # 1922538
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1EP 3 03/09/2026 FEI # 1922538
Penner Patient Care, Inc.
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor 3 02/12/2026 FEI # 3018685978
SUREPULSE MEDICAL LTD
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor 3 02/12/2026 FEI # 3018685978
SUREPULSE MEDICAL LTD
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor 3 02/12/2026 FEI # 3018685978
SUREPULSE MEDICAL LTD
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor 3 02/12/2026 FEI # 3018685978
SUREPULSE MEDICAL LTD
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor 3 02/12/2026 FEI # 3018685978
SUREPULSE MEDICAL LTD
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM 3 02/09/2026 FEI # 1000121052
Straumann USA LLC
HemosIL SynthAFax. Partial Thromboplastin Time Tests. 3 12/17/2025 FEI # 1217183
Instrumentation Laboratory
Cardiosave Hybrid 3 12/16/2025 FEI # 3001418283
Datascope Corp.

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