Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 851–900 of 7,959
- Class I
Medical Device Recall · February 27, 2026
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673DMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class II
Medical Device Recall · February 27, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027YThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254BThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CAThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model NThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081CThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257FThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be pasOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
- Class II
Medical Device Recall · February 25, 2026
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10CThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279;The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model NumbeThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting ForOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR1The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849BThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mmOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar CuttiOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 25, 2026
Olympus Corporation of the Americas
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed throOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Class II
Medical Device Recall · February 23, 2026
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
- Class II
Medical Device Recall · February 23, 2026
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001Surgical light assembly may not adequate support the weight of the ceiling cover.
- Class II
Medical Device Recall · February 20, 2026
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/CDue to a quality issue regarding the presence of burr on the finished cervical plate product.
- Class II
Medical Device Recall · February 20, 2026
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- Class II
Medical Device Recall · February 20, 2026
Radius VSM ECG pre-connected Set, REF: 4842, 4695Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- Class II
Medical Device Recall · February 19, 2026
AMO Puerto Rico Manufacturing, Inc.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A PrDue to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
- Class II
Medical Device Recall · February 18, 2026
Stryker Medical Division of Stryker Corporation
Cub Pediatric Crib, Model FL19HCribs sold in the USA are missing two access door warning labels.
- Class II
Medical Device Recall · February 18, 2026
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: NoDue to product exhibiting potential to generate either invalid or false negative results.
- Class I
Medical Device Recall · February 18, 2026
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., LtdIf heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
- Class II
Medical Device Recall · February 18, 2026
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc,Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class II
Medical Device Recall · February 18, 2026
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650ccInfusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class II
Medical Device Recall · February 18, 2026
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750ccInfusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class I
Medical Device Recall · February 18, 2026
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
- Class II
Medical Device Recall · February 18, 2026
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450ccInfusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class II
Medical Device Recall · February 18, 2026
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850ccInfusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class II
Medical Device Recall · February 18, 2026
Sterile Radiology Procedure Kits, Model Number DYNDH1491BThere is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
- Class I
Medical Device Recall · February 18, 2026
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product CodeIncreased risk of purge leaks with Generation 1 purge cassettes.