Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Nov 1, 2022 IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum ... Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... Class II Randox Laboratories Ltd.
Oct 31, 2022 Unity Total Knee System. Used for knee prosthesis in total knee replacement The internal packaging system for devices may have damage to the blisters potentially damaging th... Class II Corin Ltd
Oct 27, 2022 Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... Class II Southmedic, Inc.
Oct 17, 2022 VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-... Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f... Class II Visionsense, Ltd.
Oct 17, 2022 VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Com... Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f... Class II Visionsense, Ltd.
Oct 17, 2022 VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MM... XXX Class II Visionsense, Ltd.
Sep 28, 2022 biokitHSV-2 Rapid Test, REF: 300028001 HSV-2 rapid test may report false positive results. Class II Biokit, S.A.
Sep 23, 2022 GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (... GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. Class II GAGA PRO LIGHTING EQUIPMENT CO.,
Sep 22, 2022 Hamilton-C6 Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for... Class II Hamilton Medical AG
Aug 31, 2022 MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... Class II Micro-X Ltd.
Aug 30, 2022 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Aug 30, 2022 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Aug 22, 2022 sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... Weak skin adhesion. Class II SenTec AG
Aug 19, 2022 MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... Class III Canadian Hospital Specialties
Aug 12, 2022 Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... Due to un-commanded movement of mobile x-ray unit. Class II SEDECAL SA
Aug 9, 2022 Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Ca... Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, o... Class I Jiangsu Well Biotech Co.,Ltd.
Aug 9, 2022 Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B Products were distributed in the United States without FDA authorization or clearance. Class I DEWEI MEDICAL EQUIPMENT CO LTD
Aug 1, 2022 The Randox Serology I Positive Control contains the following analytes in hum... ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckm... Class II Randox Laboratories Ltd.
Jul 27, 2022 Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Nu... installation issues Class II BARCO NV
Jul 27, 2022 ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP,... In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. Class II GELITA MEDICAL GMBH
Jul 21, 2022 Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ... Class II Unomedical A/S
Jul 11, 2022 SafeControl handset (a component of the Sentida bed which moves and positions... When the handset is disconnected from the power mains, and mains operation is restored, the hands... Class II WISSNER-BOSSERHOFF GMBH
Jul 4, 2022 Medicina Reusable Oral syringe 1ml Code: OTH01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 2.5ml Code: OTH25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 1ml Code: OT01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 5ml Code: OTH05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 2.5ml Code: OT25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 0.5ml Code: OT005 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jun 22, 2022 Randox Cholesterol- For the quantitative in vitro determination of Cholester... Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali... Class II Randox Laboratories Ltd.
Jun 9, 2022 Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 9, 2022 Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 2, 2022 YelloPort Elite Universal Seal. For use in laparoscopic procedures. There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi... Class II Surgical Innovations Ltd
Jun 1, 2022 RayStation 9B SP1. For radiation treatment planning. An issue with propagation of treatment course information from RayStation with RayTreat to RayCar... Class II RAYSEARCH LABORATORIES AB
May 30, 2022 Positron Emission Tomography and Computed Tomography System, Model: uMI 550 The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi ... Class II Shanghai United Imaging Healthcare Co., Ltd.
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
May 18, 2022 ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 There is a potential for sporadic incidents of positive and negative biases for analyzer systems ... Class II Radiometer Medical ApS
May 13, 2022 RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC... The outer package is mislabeled and the package contains a different IOL strength. Class II Rayner Intraocular Lenses Ltd
Apr 27, 2022 X80 RADiant Photoelectric Therapy System There is a potential compatibility issue with the systems and replacement treatment applicators. Class II Xstrahl Limited
Apr 20, 2022 Proteus235- Proton Therapy System: to produce and deliver a proton beam for ... First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning ... Class II Ion Beam Applications S.A.
Apr 8, 2022 XVIVO Organ Chamber REF 19020 The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ens... Class II XVIVO PERFUSION AB
Apr 8, 2022 Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. Class II Radiometer Medical ApS
Apr 7, 2022 NanoSight NS300 Product found to not comply to Class 1 Laser safety requirement. Class II MALVERN PANALYTICAL LTD
Mar 25, 2022 CK MB Calibrator, Catalogue Number CK2393 Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... Class III Randox Laboratories Ltd.
Mar 21, 2022 ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0... Software issue for treatment plan and image management application may result in mismatch values ... Class II Varian Medical Systems Imaging Laboratory GmbH
Mar 8, 2022 OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of h... Class II SIMPLIVIA HEALTHCARE LTD.
Feb 28, 2022 NanoSight LM10 fitted with LM14 module. A laboratory instrument for determin... Product found to not comply to Class 1 Laser safety requirement. Class II MALVERN PANALYTICAL LTD
Feb 28, 2022 NanoSight LM10 fitted with LM12 module. A laboratory instrument for determin... Product found to not comply to Class 1 Laser safety requirement. Class II MALVERN PANALYTICAL LTD

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.