Browse Device Recalls
1,003 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,003 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 1,003 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use... | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo... | Class II | Olympus Corporation of the Americas |
| Dec 15, 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... | Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... | Class II | Globus Medical, Inc. |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Sep 25, 2023 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Mobile airway scope-diagnosis and observation to access airway anatomy, endot... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the u... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastrointestinal videoscope-indicated for use within the upper digestive trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal videoscope- For airway management, which includes observation to acc... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope-indicated for use within the lower digestive tract (including the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class III | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal fiberscope-airway management, which includes observation to access a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Jun 23, 2023 | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... | There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... | Class II | Scholly Fiberoptic Gmbh |
| Mar 31, 2023 | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... | The liquid buffer component in the affected test kit lots was determined to have bacterial contam... | Class I | SD Biosensor, Inc. |
| Jan 30, 2023 | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Jan 30, 2023 | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Dec 21, 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t... | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o... | Class II | Olympus Corporation of the Americas |
| Dec 8, 2022 | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... | Class II | Medtronic Navigation, Inc. |
| Nov 24, 2022 | RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used ... | Complaints of leaking packets were received. | Class I | Emergent Protective Products USA Inc |
| Nov 15, 2022 | ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive | ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d... | Class II | ConvaTec, Inc |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Jul 20, 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extr... | Class II | bioMerieux, Inc. |
| Jun 1, 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause le... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 9, 2022 | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
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.