Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 9, 2023 | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOF... | One respirator sample failed a filtration efficiency test. This respirator may not provide adequa... | Class II | O&M HALYARD, INC. |
| Aug 8, 2023 | Oculus Myopia Master , Ref 68100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| 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 8, 2023 | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model... | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could ... | Class II | GE Medical Systems Information Technologies Inc |
| Aug 8, 2023 | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| 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 | 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 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: 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 | 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): 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 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)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 | 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 | 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 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 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 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: 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 | 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: 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: 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 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 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 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 | 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 |
| 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 | 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 | 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. |
| 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 | 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 | 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 | Perifix¿ / Epidural anesthesia set, medicated | Product may be mislabeled with an incorrect lid stock label. | Class II | B. Braun Medical, Inc. |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C160. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... | 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.