Medical Device Recalls

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8,553 medical device recalls from federal enforcement feeds.

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Showing 801–850 of 8,553

Medical Device Recall · April 30, 2026
Medacta Usa Inc
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.1
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
AVID Medical, Inc.
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Class II
Medical Device Recall · April 30, 2026
MICROVENTION INC.
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selecte
Due to an increase rate of balloon pinhole defects.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
CareFusion 303, Inc.
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Class II
Medical Device Recall · April 30, 2026
AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Class I
Medical Device Recall · April 30, 2026
CareFusion 303, Inc.
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Class I
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
AVID Medical, Inc.
Halyard, Drape Pack. Kit Code: LMDP36-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Class II
Medical Device Recall · April 30, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225),
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
CareFusion 303, Inc.
BD Pyxis Mini Main REF: 349 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 30, 2026
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Class II
Medical Device Recall · April 30, 2026
Avanos Medical, Inc.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Class II
Medical Device Recall · April 29, 2026
ICU Medical, Inc.
Plum Solo Precision IV Pump, 40001-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Class II
Medical Device Recall · April 29, 2026
Boston Scientific Neuromodulation Corporation
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL,
Reusable electrodes may not meet expected performance levels.
Class II
Medical Device Recall · April 29, 2026
Beckman Coulter Biomedical GmbH
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Class II
Medical Device Recall · April 29, 2026
ICU Medical, Inc.
Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Class II
Medical Device Recall · April 29, 2026
ICU Medical, Inc.
Plum Duo Infusion Pump, 40002-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Class II
Medical Device Recall · April 29, 2026
Mozarc Medical US LLC
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curv
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Class II
Medical Device Recall · April 29, 2026
Boston Scientific Neuromodulation Corporation
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
Class II
Medical Device Recall · April 29, 2026
Boston Scientific Neuromodulation Corporation
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK
Reusable electrodes may not meet expected performance levels.
Class II
Medical Device Recall · April 28, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 7222
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Class II
Medical Device Recall · April 28, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079,
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Class II
Medical Device Recall · April 28, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Class II
Medical Device Recall · April 28, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027),
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Class II
Medical Device Recall · April 28, 2026
Mentor Texas LP
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
A single lot of expired syringes were distributed due to a distribution system control failure.
Class II
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JE
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline EBSI Kit EBSI1534
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II
Medical Device Recall · April 27, 2026
Becton Dickinson & Company
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Class I
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PED
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II
Medical Device Recall · April 27, 2026
Medline Industries, LP
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class II