Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 401 - 425 of 2,579 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.	FDA Z-3256-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 20, 2026	Details
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.	FDA Z-3194-2026	Medical Device	High	Sep 30, 2026 Recall: Jul 22, 2026	Details
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case. Gowns do not consistently meet the minimum liquid-barrier performance required.	FDA Z-3259-2026	Medical Device	High	Sep 30, 2026 Recall: Jul 31, 2026	Details
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve Labeling; Oxygen Cylinders do not contain required medical gas labeling	FDA Z-3223-2026	Medical Device	High	Sep 30, 2026 Recall: Jul 28, 2026	Details
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.	FDA Z-3215-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 6, 2026	Details
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.	FDA Z-3269-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 10, 2026	Details
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,	FDA Z-3216-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 19, 2026	Details
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S); A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.	FDA Z-3236-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.	FDA Z-3244-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 19, 2026	Details
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).	FDA Z-3258-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 12, 2026	Details
MR 5300 Model Number (REF): 1. 782110, 2. 782152; A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.	FDA Z-3241-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.	FDA Z-3242-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.	FDA Z-3231-2026	Medical Device	High	Sep 30, 2026 Recall: Jul 24, 2026	Details
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622 A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.	FDA Z-3217-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.	FDA Z-3253-2026	Medical Device	High	Sep 30, 2026 Recall: May 6, 2026	Details
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X); A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.	FDA Z-3239-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1; Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.	FDA Z-3225-2026	Medical Device	High	Sep 30, 2026 Recall: Jul 29, 2026	Details
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722 A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.	FDA Z-3219-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.	FDA Z-3140-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 11, 2026	Details
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.	FDA Z-3251-2026	Medical Device	High	Sep 30, 2026 Recall: Feb 19, 2019	Details
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.	FDA Z-3233-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624 A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.	FDA Z-3218-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 21, 2026	Details
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F. Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.	FDA Z-3229-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 10, 2026	Details
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.	FDA Z-3247-2026	Medical Device	High	Sep 30, 2026 Recall: Aug 19, 2026	Details
Convenience kits CATARACT PACK DYNJ59881A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.	FDA Z-3210-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details

Showing 401 - 425 of 2,579 product recalls

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Medical Device Recalls Today

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