FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 3, 2026. New recalls appear here on the FDA's own publishing schedule.

59,102 recall(s)

Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 26, 2026

REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

Reason: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Root cause: Software Design Change

Recalling firm: Beckman Coulter Inc.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY.Recall #Z-2889-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jul 6, 2026

Atellica CH Urine Albumin REF: 11537225

Reason: processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

Root cause: Under Investigation by firm

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Cura¿ao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿Recall #Z-2890-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 17, 2026

Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System.

Reason: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Root cause: Under Investigation by firm

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2891-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 17, 2026

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.

Reason: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Root cause: Under Investigation by firm

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2892-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 17, 2026

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Reason: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Root cause: Under Investigation by firm

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2893-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jul 1, 2026

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Reason: Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

Root cause: Process control

Recalling firm: Aniara Diagnostica LLCType: Calibrator, SecondaryDistribution: US Nationwide distribution in the states of IL, NC, TN.Recall #Z-2894-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jul 1, 2026

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Root cause: Process control

Recalling firm: Aniara Diagnostica LLCType: Calibrator, Multi-Analyte MixtureDistribution: US Nationwide distribution in the states of IL, NC, TN.Recall #Z-2895-2026

Open, ClassifiedPosted Aug 5, 2026·Initiated Jul 1, 2026

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Root cause: Process control

Recalling firm: Aniara Diagnostica LLCType: Plasma, Coagulation ControlDistribution: US Nationwide distribution in the states of IL, NC, TN.Recall #Z-2896-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jun 30, 2026

Merge PACS, medical imaging diagnostic workstation

Reason: Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

Root cause: Software Design Change

Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: Worldwide distribution - US Nationwide and the countries of Canada, and UK.Recall #Z-2874-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jun 30, 2026

Merge OrthoPACS, medical imaging diagnostic workstation

Root cause: Software Design Change

Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: Worldwide distribution - US Nationwide and the countries of Canada, and UK.Recall #Z-2875-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jun 29, 2026

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Reason: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

Root cause: Software design

Recalling firm: GE Medical Systems Information Technologies IncType: ElectrocardiographDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.Recall #Z-2876-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jul 16, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Reason: Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Root cause: Under Investigation by firm

Recalling firm: Biofire DefenseDistribution: U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.Recall #Z-2877-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jul 10, 2026

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592

Reason: Portrait Core Services Software version V1.2.0 Security Vulnerability

Root cause: Software design

Recalling firm: GE Medical Systems Information Technologies IncType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.Recall #Z-2878-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jun 26, 2026

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Reason: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Root cause: Under Investigation by firm

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Enzyme Immunoassay, LidocaineDistribution: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.Recall #Z-2880-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated Jun 26, 2026

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Reason: out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Root cause: Under Investigation by firm

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Radioimmunoassay, Tricyclic Antidepressant DrugsDistribution: Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.Recall #Z-2881-2026

Open, ClassifiedPosted Aug 4, 2026·Initiated May 15, 2024

Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

Reason: This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned.

Root cause: Reprocessing Controls

Recalling firm: Happiest Baby, IncType: Infant Supine Sleep SystemDistribution: US Nationwide distribution in states of PA, WA, CA, NJ.Recall #Z-2882-2026

Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 11, 2026

Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and can be charged with either a wired or wireless charger. The system is intended to interface wirelessly to an external tablet or display when used with the OXOS Device App. The MC2 utilizes an infrared Tracking System and Viewfinder that allows the operator to position the emitter within a safe source-to-image distance (SID) and allows the operator to visualize the anatomy and x-ray field projection prior to initiating an x-ray acquisition. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance. Component: The MC2 Portable X-Ray System is not a component.

Reason: Due to a defective circuit board that overheats

Root cause: Process change control

Recalling firm: Oxos Medical IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.Recall #Z-2857-2026

Open, ClassifiedPosted Aug 3, 2026·Initiated May 21, 2026

Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791

Reason: Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.

Root cause: Nonconforming Material/Component

Recalling firm: Medical Action Industries, Inc. 306Type: Dialysis Administration KitDistribution: US Nationwide distribution in the state of CA.Recall #Z-2858-2026

Open, ClassifiedPosted Aug 3, 2026·Initiated May 22, 2026

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Reason: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

Root cause: Process design

Recalling firm: Innovasis, IncType: Thoracolumbosacral Pedicle Screw SystemDistribution: US Nationwide distribution in the states of TX, CA.Recall #Z-2859-2026

Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 24, 2026

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900

Reason: Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

Root cause: Under Investigation by firm

Recalling firm: Maquet Critical Care ABType: Gas-Machine, AnesthesiaDistribution: Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV.Recall #Z-2860-2026