Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jan 20, 2023 Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 SenSight Connector Plug, Model Number B31061. Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... Class II Medtronic Neuromodulation
Jan 20, 2023 Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 18, 2023 Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. Labeling being updated to assure user is securing the siderail to a locked position to prevent po... Class II Linet Spol. S.r.o.
Jan 5, 2023 abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... Class III S & MOHR AMERICA, S.A. DE C.V.
Jan 3, 2023 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... Class III Owens & Minor Distribution, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 23, 2022 Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... Class II Philips Healthcare (Suzhou) Co., Ltd.
Dec 22, 2022 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... Class II Encore Medical, LP
Dec 22, 2022 Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... Class II Siemens Medical Solutions USA, Inc
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... Label with the incorrect component listed on the inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 22, 2022 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... Product Mislabeled on the outer bag and inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 Mammotome MammoStar Biopsy Site Identified, REF STAR1401 The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loade... Class II Carbon Medical Technologies, Inc.
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 15, 2022 PICC KIT, 10/CS, ACCESS MEDICAL LABEL Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HIGH V+ Spinal Cement System REF T040321K Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration d... Class II TEKNIMED SAS
Dec 12, 2022 BD Pyxis MedBank System - Product Label/labeling pending Due to customer complaints related to the MedBank software which may indicate that a different me... Class II CareFusion 303, Inc.
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Re... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY,... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 5, 2022 Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 mislabeled product Class III Young Dental Manufacturing I, LLC
Dec 2, 2022 Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-182... The stylet is longer than specified on the label Class II Remington Medical, Inc.
Nov 28, 2022 Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes... Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer... Class I Universal Meditech Inc.
Nov 23, 2022 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... The product is labeled with the incorrect expiration date. Class II Covidien, LLC

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.