Browse Device Recalls
966 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 966 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 966 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2024 | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | Contamination with foreign substance matter | Class II | 3M Company - Health Care Business |
| Jul 10, 2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 2, 2024 | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... | Class II | Argon Medical Devices, Inc |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been inserted into the te... | Class II | Cepheid |
| Jun 13, 2024 | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| Jun 13, 2024 | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov... | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... | Class II | Steris Corporation |
| May 13, 2024 | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and... | One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contami... | Class II | SIGHT DIAGNOSTICS LTD |
| May 13, 2024 | Non-sterile, single use, disposable gloves intended for medical purposes to b... | Firm received complaints regarding skin irritation when using the gloves, disintegration of the g... | Class II | SVS LLC |
| Apr 17, 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... | Potential contamination of the product with latex adhesive residual. | Class II | Cardinal Health 200, LLC |
| Mar 20, 2024 | 24K Premium Lense, Distributed by Updream Inc. | Contact lenses recalled due to potential bacterial contamination. | Class II | Ontact Inc |
| Feb 29, 2024 | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix ... | Products were found to have confirmed drug cross contamination prior to release may lead to incor... | Class II | Becton Dickinson & Co. |
| 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. |
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.