Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
May 26, 2021 Azurion systems with software release R1.x In the Azurion system, the user can add a new study to a patient by selecting the option Add St... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 26, 2021 Azurion systems with software release R2.0.x In the Azurion system, the user can add a new study to a patient by selecting the option "Add Stu... Class II Philips Healthcare
May 26, 2021 Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used wi... Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refil... Class II Flowonix Medical Inc
May 26, 2021 Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Mon... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with bui... Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed con... Class II Owen Mumford USA, Inc.
May 26, 2021 Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure M... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx On... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Steril... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Proteus 235-Proton Therapy System if the user forgets to select the trigger input manually while beam gating is prescribed for the... Class II Ion Beam Applications S.A.
May 26, 2021 Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 25, 2021 OxyMask O2 Adult REF OM-1125-14 Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in ... Class II Southmedic, Inc.
May 25, 2021 Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. ... The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can... Class II Remote Diagnostic Technologies Ltd.
May 25, 2021 Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Lar... Potential for mold contamination (Aspergillus vadensis) Class II Medline Industries Inc
May 21, 2021 Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic im... The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... Class II Canon Medical System, USA, INC.
May 21, 2021 Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Prod... The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... Class II Canon Medical System, USA, INC.
May 21, 2021 Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI Sys... The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... Class II Canon Medical System, USA, INC.
May 21, 2021 Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usag... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product... The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... Class II Canon Medical System, USA, INC.
May 21, 2021 CARESCAPE PDM-Masimo SpO2. Physiological data monitor. Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power d... Class II GE Healthcare, LLC
May 21, 2021 Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Pro... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product ... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R ... Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contam... Class II Sunstar Americas, Inc.
May 21, 2021 Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - P... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Numbe... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Ca... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 20, 2021 FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Fre... The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% comp... Class II The Binding Site Group, Ltd.
May 19, 2021 DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For U... Catheter kits contained the incorrect micro-introducers. Class II Bard Access Systems Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens wi... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable C... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Con... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposabl... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imagin... The firm is aware of a issue with ultrasound software that results in unintended video frames b... Class II Caption Health
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. int... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-0715... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 DigitalDiagnost C90 High Performance. radiography and fluoroscopy system Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... Class II Philips Medical Systems DMC GmbH
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. intr... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Co... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens ... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire ... Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires... Class II Bard Access Systems Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision 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.