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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2021 | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB270... | Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment ... | Class II | Lymol Medical Corporation |
| Jul 29, 2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... | Class III | Sentinel CH SpA |
| Jul 28, 2021 | Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number... | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... | Class II | Roche Diabetes Care, Inc. |
| Jul 28, 2021 | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockya... | Missing splash guard which may expose users to hazardous materials. . | Class II | Beckman Coulter Inc. |
| Jul 28, 2021 | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model number... | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... | Class II | Roche Diabetes Care, Inc. |
| Jul 28, 2021 | Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbe... | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... | Class II | Roche Diabetes Care, Inc. |
| Jul 28, 2021 | Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number ... | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... | Class II | Roche Diabetes Care, Inc. |
| Jul 28, 2021 | Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 27, 2021 | Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Ph... | Contact lens solution may contain foreign material | Class II | Contamac Solutions, Inc. |
| Jul 27, 2021 | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-Co... | Products may have been distributed to customers other than laboratories certified under the Clini... | Class II | Versea Diagnostics LLC |
| Jul 27, 2021 | REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle,... | Potential for needle protector to become fully dislodge exposing infusion needle which could resu... | Class II | Bard Peripheral Vascular Inc |
| Jul 27, 2021 | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qual... | Products may have been distributed to customers other than laboratories certified under the Clini... | Class II | Versea Diagnostics LLC |
| Jul 27, 2021 | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential D... | Products may have been distributed to customers other than laboratories certified under the Clini... | Class II | Versea Diagnostics LLC |
| Jul 27, 2021 | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy... | The sterile barrier seal may be compromised. | Class II | Clarus Medical, Llc |
| Jul 27, 2021 | FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differen... | Products may have been distributed to customers other than laboratories certified under the Clini... | Class II | Versea Diagnostics LLC |
| Jul 26, 2021 | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan i... | Class II | Elekta Inc |
| Jul 26, 2021 | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impres... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 26, 2021 | Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impress... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 26, 2021 | Alinity ci-series System Control Module clinical chemistry and immunoassay an... | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... | Class II | Abbott Laboratories |
| Jul 26, 2021 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impress... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 26, 2021 | Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impress... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 26, 2021 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impressi... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 26, 2021 | Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo Universal, Product number DS2000X11B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impressi... | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... | Class II | Paltop Advanced Dental Solutions Ltd |
| Jul 23, 2021 | Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jul 23, 2021 | Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product cod... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jul 23, 2021 | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 c... | There is potential for nonsterility of product due to a possible defect in the pouch seal. | Class II | Mivi Neuroscience Inc |
| Jul 23, 2021 | MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigationa... | There is potential for nonsterility of product due to a possible defect in the pouch seal. | Class II | Mivi Neuroscience Inc |
| Jul 23, 2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x... | Class II | Merge Healthcare, Inc. |
| Jul 23, 2021 | AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 | The kit contains the wrong vial tray in the package. | Class II | BioMimetic Therapeutics, LLC |
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jul 23, 2021 | Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample K... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jul 22, 2021 | BD" Mouse IgG2a Isotype Control APC X39 ASR | Complaints have been received for performance issues related to high background and staining. th... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 22, 2021 | EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7... | Ultrasound system control panel arm swivel lock could fail, which could cause the control panel a... | Class II | Philips Ultrasound Inc |
| Jul 22, 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET... | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirm... | Class II | Baxter Healthcare Corporation |
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.