Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

About medical device recalls

Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.

For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.

If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.

1551–1575 of 13398

HighFDA (Devices)·Z-0637-2026·2025-12-03
Extension Set Recall: Risk of Medication Backflow in IV Administration
B Braun Medical is recalling 61,423 extension sets used with IV pumps due to potential backflow of medication and inability to prime. The recalled sets are distributed worldwide.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0676-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime properly.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0724-2026·2025-12-03
Xpert MTB/RIF TB diagnostic test recalled due to stability failure
Cepheid is recalling 9,880 units of the Xpert MTB/RIF TB diagnostic device after product testing failed to meet expected stability criteria, potentially affecting test accuracy.
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2026·2025-12-03
IV Administration Set Risk of Medication Backflow and Occlusion
B. Braun Medical Inc. recalls AESTHESIA IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. Approximately 4,488 units were distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0601-2026·2025-12-03
NICO BrainPath Surgical Instruments Recalled for Undisclosed Latex in Packaging
Stryker is recalling NICO BrainPath neurosurgical instruments because packaging tape contains latex despite products being labeled as latex-free, which could cause allergic reactions in sensitive individuals.
Product
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling Blood Administration Sets (catalog 490196) due to potential backflow of medication between IV containers and inability to prime. The recall affects 7,344 units distributed worldwide.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET 124 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0582-2026·2025-12-03
Emdogain Dental Device Recalled for Unintended Clinical Use Risk
Straumann USA recalls Emdogain dental devices intended for demonstration purposes only due to risk of unintended patient use. 61 units affected across ten US states.
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0659-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls IV administration sets used with its infusion pumps due to potential backflow of medication into primary IV containers and inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Priming Failure Risk
B Braun Medical IV administration sets carry risk of medication backflow into primary containers and inability to prime. Affects approximately 20.7 million units distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0679-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical recalls an IV administration set used with gravity and pump infusion systems due to potential backflow of medication into primary IV containers and inability to prime. Approximately 15,250 units distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0632-2026·2025-12-03
IV Administration Extension Set Recalled Due to Medication Backflow Risk
B Braun Medical is recalling 13,600 extension sets used in IV administration systems due to potential backflow of medication and inability to prime. The affected product may cause medication to flow back into primary containers.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ B/C VLV, ULTRAPORT, 57 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0656-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow Risk
B. Braun Medical Inc is recalling IV Administration Sets used with its infusion pumps due to potential medication backflow from secondary to primary IV containers and inability to prime properly.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0639-2026·2025-12-03
Extension Sets Recalled by B Braun for Medication Backflow Risk
B Braun Medical Inc is recalling 300 units of extension sets used in IV administration with certain pumps due to potential for medication backflow and inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT/2INJ/FLBL/FML LRLK/CV 34; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0607-2026·2025-12-03
FDA Recalls B Braun IV Administration Sets for Medication Backflow Risk
B Braun Medical Inc recalls 104,784 IV administration sets used with multiple infusion pumps due to potential medication backflow from secondary to primary containers and inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0651-2026·2025-12-03
IV Administration Set Recalled for Backflow Risk and Occlusion Issues
B Braun Medical Inc is recalling IV administration sets that may allow medication to flow backward from secondary containers into primary containers and may fail to prime properly.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 3 CARESITE ULTRA ZER
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0712-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 554,015 units of SafeDAY IV administration sets due to potential medication backflow from secondary containers into primary containers and inability to prime the IV line.
Product
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCO
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0688-2026·2025-12-03
IV Administration Sets recalled for potential medication backflow and occlusion risk
B Braun Medical is recalling IV administration sets that could allow medication backflow from secondary into primary IV containers and may prevent proper priming. The recall affects 28,344 units worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ B/C VALVE,1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0629-2026·2025-12-03
IV Extension Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical is recalling extension sets for intravenous administration due to potential medication backflow from secondary containers into primary containers and inability to prime properly. Approximately 2,100 units distributed worldwide are affected.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ANES SET W/DUAL FEM.LL SAFEPORT MAN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0598-2026·2025-12-03
Galaxy System Bronchoscope Inaccessible Operating Instructions Recall
Noah Medical Corporation recalls 47 Galaxy System bronchoscopic devices because password protection prevents users from accessing required operating instructions.
Product
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0686-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow Hazard
B. Braun Medical's IV administration sets (catalog 490491) are recalled due to potential medication backflow from secondary containers into primary containers and inability to prime (occlusion).
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET, 138
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0709-2026·2025-12-03
Outlook IV administration sets recalled due to backflow and occlusion risk
B. Braun Medical is recalling approximately 162,648 Outlook IV administration sets worldwide due to potential medication backflow from secondary into primary IV containers and inability to prime. No injuries or illnesses have been reported.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0700-2026·2025-12-03
B Braun IV Administration Sets Recalled for Potential Backflow Risk
B Braun Medical Inc recalls IV Administration Sets for potential medication backflow from secondary to primary containers and inability to prime during infusion.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0589-2026·2025-12-03
Vena Cava Filter System May Have Insertion Complications
Argon Medical Devices is recalling the Option ELITE Vena Cava Filter System due to increased insertion resistance that could cause procedural delays or venous injuries if excessive force is applied. The recall affects 1,794 units in the U.S.
Product
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0715-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling Vista IV administration sets due to potential backflow of medication from secondary to primary containers and inability to prime. Approximately 74,652 units were distributed worldwide.
Product
Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. VISTA BASIC PUMP IV SET W/ 15 DROP/ML;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0689-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Failure Risk
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. Approximately 25,728 units were distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, QUAD MANIFOLD
Category
Medical Device
Distribution
0 states

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