Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 34,608 FDA device recalls — Class II.

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DateProductReasonClassFirm
Feb 27, 2026 SIGNA Premier systems Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of... Class II GE Healthcare LLC
Feb 25, 2026 Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO AN... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYR... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TR... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440 The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 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 T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJS... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number:... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PAC... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO P... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model N... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DY... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 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 03.4... Class II Synthes (USA) Products LLC
Feb 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 03.4... Class II Synthes (USA) Products LLC
Feb 25, 2026 Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 23, 2026 Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 Surgical light assembly may not adequate support the weight of the ceiling cover. Class II Stryker Communications
Feb 23, 2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN):... A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the s... Class II Siemens Healthcare Diagnostics, Inc.
Feb 20, 2026 Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL... Due to a quality issue regarding the presence of burr on the finished cervical plate product. Class II Clariance-SAS
Feb 19, 2026 Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ... Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to... Class II AMO Puerto Rico Manufacturing, Inc.
Feb 18, 2026 XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number ... Units from one lot were mislabeled with an incorrect part number, identifying the device as a sho... Class II XTANT Medical Holdings, Inc
Feb 18, 2026 Sterile Radiology Procedure Kits, Model Number DYNDH1491B There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which m... Class II Medline Industries, LP
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... Class II Baxter Healthcare Corporation
Feb 18, 2026 Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog N... Due to product exhibiting potential to generate either invalid or false negative results. Class II Hologic, Inc.
Feb 18, 2026 Cub Pediatric Crib, Model FL19H Cribs sold in the USA are missing two access door warning labels. Class II Stryker Medical Division of Stryker Corporation
Feb 18, 2026 Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Pe... Due to adapter not being properly aligned or locked in place. Class II Elekta, Inc.
Feb 17, 2026 See Luer Cap Set, MPC-130, set, administration, intravascular Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer C... Class II Molded Products Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.