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.

1676–1700 of 13464

HighFDA (Devices)·Z-0647-2026·2025-12-03
IV Administration Set Recall Due to Backflow and Priming Occlusion Risk
B Braun Medical's IV administration sets may allow medication backflow into primary containers and prevent proper priming. FDA issued a Class II recall for the affected sets used in multiple pump models.
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 15D, 2 B/C VLV, 3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0640-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Pump Occlusion Failure
B Braun Medical Inc is recalling multiple IV administration sets used with gravity and pump infusion systems. The sets pose a risk of medication backflow between containers and inability to prime the pump.
Product
Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0675-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling 65,232 IV Administration Sets used with multiple infusion pump models due to potential backflow of medication from secondary containers into primary 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. Catalog Number: 490549; Pri
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0633-2026·2025-12-03
Extension Set for IV Administration May Allow Medication Backflow
B Braun Medical extension sets used in gravity and pump IV administration may allow medication from secondary containers to flow backward into primary containers, interfering with medication delivery.
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. EXTENSION SET W/ B/C VALVE 53 in.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0684-2026·2025-12-03
IV Administration Set Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The recall affects 126,050 units with worldwide distribution.
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 ADM 15D 2 CARESITE, SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0618-2026·2025-12-03
Blood Administration Sets: Risk of Medication Backflow and Occlusion
B Braun Medical Inc is recalling Y-type blood administration sets due to potential backflow of medication from secondary IV containers into primary containers, which could also prevent proper priming.
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, 3 CARS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0642-2026·2025-12-03
B Braun IV Administration Sets recalled for potential medication backflow
B Braun Medical Inc is recalling IV Administration Sets due to potential for medication backflow from secondary to primary containers. The defect may also prevent proper priming.
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 numbers: 1. IV ADMIN SET, 10 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0720-2026·2025-12-03
FDA Recalls Mindray V90 Vaporizer Over Potential Anesthesia Leakage
Mindray is recalling 148 units of its V90 Electronic Vaporizer with A9 Anesthesia System due to potential anesthesia leakage in the safety filling adapter. The affected units were distributed to healthcare facilities in the US, Canada, and Puerto Rico.
Product
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: Th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0599-2026·2025-12-03
NICO Myriad Surgical Handpieces Recalled for Latex Contamination in Packaging
Stryker has recalled NICO Myriad surgical handpieces because packaging tape contains latex despite products being labeled latex-free. Latex exposure could cause allergic reactions in sensitive patients.
Product
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2026·2025-12-03
B Braun ADDitIV IV Administration Sets Recalled for Medication Backflow
B Braun recalled over 43,900 ADDitIV gravity and pump IV administration sets worldwide due to potential medication backflow from secondary bags into primary bags and inability to prime.
Product
ADDitIV 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. Primary Gravity IV Set, 2 Non-Needle-Fre
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0646-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Occlusion Risk
B Braun IV administration sets may allow medication backflow from secondary containers into primary containers or fail to prime. Approximately 1,019 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 SET W/2 CARESITE & 1 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0605-2026·2025-12-03
B Braun ADDitIV IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling approximately 12,700 ADDitIV IV administration sets worldwide due to potential backflow of medication from secondary to primary containers and inability to prime.
Product
ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0624-2026·2025-12-03
Caresite IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling Caresite IV administration sets due to potential backflow of medication from secondary IV lines into primary containers and inability to prime. Over 12 million units are affected worldwide.
Product
Caresite 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. Primary Gravity IV Set with 2 CARESITE¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0594-2026·2025-12-03
CareLink Clinic Software Error Causes Incorrect Glucose Display
CareLink Clinic diabetes management software contains an error that displays incorrect 24-hour glucose data, potentially leading to improper therapy decisions and abnormal blood glucose levels.
Product
CareLink Clinic, REF: MMT-7350
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0661-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets used with certain infusion pumps due to potential backflow of medication and inability to prime. Approximately 259,392 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 W/ 2 CARESITE,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0614-2026·2025-12-03
FDA Recalls Anesthesia IV Sets Due to Medication Backflow and Priming Failure
B Braun Medical Inc is recalling approximately 58,752 anesthesia IV sets worldwide due to potential backflow of medication from secondary containers into 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 117 IN.; Catalog N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0672-2026·2025-12-03
IV Administration Set Backflow and Occlusion Recall by B. Braun
B. Braun Medical is recalling IV administration sets due to potential backflow of medication from secondary to primary containers and inability to prime, affecting 1,080 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 DROP, 132 I
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0595-2026·2025-12-03
Lab Analyzer Module May Generate Unlabeled Secondary Sample Tubes
The FlexLab laboratory analyzer's Aliquoter Module may produce secondary sample tubes without labels or with mismatched labels during maintenance procedures. This could result in delayed or incorrect test results in laboratory operations.
Product
FlexLab (FLX); Version: FLX-217-10;
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0578-2026·2025-12-03
FoundationOne Liquid CDx Test Reports Sent Without Required Claims Information
FoundationOne Liquid CDx (F1LCDx) TECH-0009 version 6.0 test reports were sent to customers without the required companion diagnostic Claims Page. Amended reports with complete information were distributed within 7 days.
Product
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0585-2026·2025-12-03
Remel Laboratory Culture Media Recalled for Potential Contamination
Remel recalled two laboratory culture media products due to potential contamination that may discolor the media. Products distributed nationwide and internationally.
Product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0581-2026·2025-12-03
Alcon Constellation Vitrectomy Instruments Class II Recall
Alcon Research LLC is recalling Constellation Ultravit 10K and Hypervit 20K vitrectomy instruments (eye surgery devices). Approximately 28,323 units were distributed worldwide; the recall remains ongoing.
Product
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0577-2026·2025-12-03
Medical device test result reports issued without required claims page
Foundation Medicine issued reports for its FoundationOne CDx diagnostic test that were missing the companion diagnostic claims page. The documentation was corrected and reissued within 7 days.
Product
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0596-2026·2025-12-03
FlexLab Aliquoter Module May Generate Unlabeled Sample Tubes
The FlexLab's Aliquoter Module may produce sample tubes without labels or with mismatched labels, potentially causing delayed or incorrect lab results if operators don't properly clear the printer buffer during maintenance.
Product
FlexLab (FLX); Version: FLX-217-40;
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0430-2026·2025-11-26
BD Alaris Infusion Pump Module 8100 Recall: Risk of Malfunction if Dropped
CareFusion recalls BD Alaris infusion pump modules distributed worldwide. Dropping or jarring may damage the bezel assembly, causing under-infusion, over-infusion, or pump failure; affected pumps must be removed from service and inspected by qualified personnel.
Product
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0488-2026·2025-11-26
FDA Recalls TMJ Bilateral Implants Due to Screw Hole Position Discrepancy
TMJ Solutions Inc is recalling 63 TMJ bilateral implants (model CHG020) due to a discrepancy in screw hole positioning. The affected implants were distributed to patients in multiple U.S. states and internationally to Canada, Spain, and Brazil.
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Category
Medical Device
Distribution
15 states

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