Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2023 | ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... | There is a potential for a positive bias on Quality Control (QC) and patient sample results when ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 8, 2023 | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 | Centered glenosphere box may contain an eccentric glenosphere. | Class II | FX SHOULDER |
| Aug 8, 2023 | 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | Oculus Pentacam AXL , Ref 70100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 7, 2023 | Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... | Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical... | Class II | Thoratec Corp. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakawa... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, All... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 5, 2023 | VITROS XT Chemistry Products TBIL-ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 5, 2023 | VITROS XT Chemistry Products ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 4, 2023 | DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... | Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 4, 2023 | DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 | there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Che... | Class II | Randox Laboratories Ltd. |
| Aug 3, 2023 | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | Some surgical glove sterile pouches were not completely sealed. | Class II | Ansell Healthcare Products LLC |
| Aug 3, 2023 | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for ... | It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide e... | Class II | Accuray Incorporated |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | 3T Heater Cooler System, REF: 16-02-85 | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance sch... | Class II | LivaNova Deutschland GmbH |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V2... | Some surgical glove sterile pouches were not completely sealed. | Class II | Ansell Healthcare Products LLC |
| Aug 3, 2023 | MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 | 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the ti... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 2, 2023 | Incisive CT, software version 5.0 | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... | Class II | Philips Healthcare |
| Aug 1, 2023 | COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four i... | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing ... | Class II | Avanos Medical, Inc. |
| Aug 1, 2023 | GS70 Salus Surgical Table, Product Code 18-070-70 | When the control of the operating table was used in Bluetooth mode, the operating table continued... | Class II | Skytron, LLC |
| Aug 1, 2023 | GS70H Salus Surgical Table, Product Code 18-071-70 | When the control of the operating table was used in Bluetooth mode, the operating table continued... | Class II | Skytron, LLC |
| Aug 1, 2023 | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and effi... | Class II | SynCardia Systems LLC |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... | Class II | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were identifying autofill failure conditions on the devices causing pump stops. | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... | Class II | Datascope Corp. |
| Jul 31, 2023 | Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... | The incorrect product labeling was applied to the product indicating the wrong size of product. | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were identifying autofill failure conditions on the devices causing pump stops. | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was discovered that users w... | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... | Class I | Datascope Corp. |
| Jul 31, 2023 | Perifix¿ / Epidural anesthesia set, medicated | Product may be mislabeled with an incorrect lid stock label. | Class II | B. Braun Medical, Inc. |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was discovered that users w... | Class I | Datascope Corp. |
| Jul 27, 2023 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific 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.