Class IIIOngoingZ-1500-2026
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa
The device does not bear a unique device identifier.
Penner Patient Care, I…NEMar 18, 2026
Class III recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 127 recalls
Class IIIOngoingZ-1499-2026
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa
The device does not bear a unique device identifier.
Penner Patient Care, I…NEMar 18, 2026
Class IIIOngoingZ-1360-2026
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDFeb 18, 2026
Class IIIOngoingZ-1359-2026
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDFeb 18, 2026
Class IIIOngoingZ-1358-2026
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDFeb 18, 2026
Class IIIOngoingZ-1357-2026
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDFeb 18, 2026
Class IIIOngoingZ-1356-2026
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDFeb 18, 2026
Class IIIOngoingZ-1337-2026
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Straumann USA LLCMAFeb 18, 2026
Class IIIOngoingZ-0938-2026
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
Instrumentation Labora…MADec 24, 2025
Class IIIOngoingZ-0932-2026
Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.NJDec 24, 2025
Class IIIOngoingZ-0931-2026
Datascope Corp. recalls Cardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.NJDec 24, 2025
Class IIIOngoingZ-0896-2026
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer Sys…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025