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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

21,444medical device recall records

2,151FDA Class I records

8firms with 5+ records

MEDLINE INDUSTRIES, LP…730 records

Database records

Records — page 82

21,444 detailed records are currently available in this category.

Medical DeviceDec 10, 2025

Philips IntelliVue MP50. Product Number: M8004A recall — FDA Z-0854-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue MP80. Product Number: M8008A recall — FDA Z-0857-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX100 recall — FDA Z-0861-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue MP40. Product Number: M8003A recall — FDA Z-0853-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Multi Measurement Server X2 recall — FDA Z-0859-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Enterix InSure ONE Fecal Immunochemical Test recall — FDA Z-0725-2026

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Class IIFDA: OngoingEnterix, Inc.

Medical DeviceDec 10, 2025

Philips IntelliVue MP60. Product Number: M8005A recall — FDA Z-0855-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue MP5. Product Number: M8105A recall — FDA Z-0850-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue MP20. Product Number: M8001A recall — FDA Z-0851-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX600 recall — FDA Z-0866-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Illumina Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument recall — FDA Z-0884-2026

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue,…

Class IIFDA: OngoingIllumina, Inc.

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX400 recall — FDA Z-0862-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Multi-Measurement Module X3 recall — FDA Z-0860-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Accriva Diagnostics Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR recall — FDA Z-0880-2026

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Class IIFDA: OngoingAccriva Diagnostics, Inc.

Medical DeviceDec 10, 2025

Siemens Medical Solutions USA MAMMOMAT Revelation recall — FDA Z-0877-2026

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for…

Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX550 recall — FDA Z-0865-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX750 recall — FDA Z-0868-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue Patient Monitor MX450 recall — FDA Z-0863-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 10, 2025

Philips IntelliVue MP70. Product Number: M8007A recall — FDA Z-0856-2026

Potential issue where the IntelliVue monitors did not alarm.

Class IIFDA: OngoingPhilips North America LLC

Medical DeviceDec 3, 2025

B Braun Medical Blood Administration Set utilized in gravity IV administration sets and pump recall — FDA Z-0617-2026

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Class IIFDA: OngoingB Braun Medical Inc.

Medical DeviceDec 3, 2025

B Braun Medical IV Administration Set utilized in gravity IV administration sets and pump recall — FDA Z-0656-2026

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Class IIFDA: OngoingB Braun Medical Inc.

Medical DeviceDec 3, 2025

B Braun Medical Blood Administration Set utilized in gravity IV administration sets and pump recall — FDA Z-0616-2026

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Class IIFDA: OngoingB Braun Medical Inc.

Medical DeviceDec 3, 2025

B Braun Medical SafeDAY set utilized in gravity IV administration sets and pump recall — FDA Z-0712-2026

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Class IIFDA: OngoingB Braun Medical Inc.

Medical DeviceDec 3, 2025

B Braun Medical IV Administration Set utilized in gravity IV administration sets and pump recall — FDA Z-0647-2026

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Class IIFDA: OngoingB Braun Medical Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.