Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... | Class II | BioPro, Inc. |
| Feb 1, 2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... | Class II | BioPro, Inc. |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... | Class II | BioPro, Inc. |
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... | Class II | BioPro, Inc. |
| Jan 31, 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... | Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 31, 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... | Class I | SD Biosensor, Inc. |
| Jan 31, 2022 | INFX-8000V. For radiographic and fluoroscopic studies and intervention. | The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. | Class II | Canon Medical System, USA, INC. |
| Jan 31, 2022 | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis... | This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of... | Class II | B. Braun Medical, Inc. |
| Jan 28, 2022 | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF... | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted... | Class II | GE Healthcare, LLC |
| Jan 28, 2022 | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI:... | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | Class II | Remote Diagnostic Technologies Ltd. |
| Jan 28, 2022 | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S | One lot of product was distributed in unsealed packaging | Class II | Brasseler USA, Medical L.L.C. |
| Jan 28, 2022 | Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 104... | Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abn... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 28, 2022 | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... | Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... | Class II | B Braun Medical Inc |
| Jan 28, 2022 | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 | Due to partially assembled valved dressing that has a hole within it instead of the intended non-... | Class II | Sam Medical Products |
| Jan 28, 2022 | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... | Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... | Class II | B Braun Medical Inc |
| Jan 27, 2022 | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... | Class II | Medtronic MiniMed |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-ca... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, nar... | Excessive ultraviolet-C radiation | Class II | IN MY BATHROOM LLC |
| Jan 27, 2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusi... | Failed stability specifications for reagent kits that may result in false negative test results. | Class II | Hologic, Inc |
| Jan 27, 2022 | HeartWare Ventricular Assist Device (HVAD) System | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B... | Class II | Heartware, Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit | The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purp... | Class I | E25Bio, Inc. |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Jan 25, 2022 | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... | The product was incorrectly shipped at room temperature rather than refrigerated. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 25, 2022 | CoolSeal Generator, REF: CSL-200-50 | A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 sta... | Class II | Bolder Surgical, LLC |
| Jan 24, 2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as ... | Class III | Volcano Corp |
| Jan 24, 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 24, 2022 | Matrix Clinical Solution At-Home COVID-19 Test | Due to COVID-19 Test not being authorized for home sample collection. | Class II | Matrix Medical Network |
| Jan 24, 2022 | Philips Respironics V60 Plus Ventilator Part Number 1138747 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 24, 2022 | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the sa... | Class II | Argon Medical Devices, Inc |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 21, 2022 | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, ... | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | Class II | Stryker Sustainability Solutions |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... | A risk for product contamination was identified for the affected product lot. If used, there is a... | Class II | NeuMoDx Molecular Inc |
| Jan 21, 2022 | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shou... | Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down alo... | Class II | NRT X-RAY A/S |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 20, 2022 | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle ... | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Due to a component in the hemodialysis console there is the possibility of heat-related damage th... | Class II | Outset Medical, Inc. |
| Jan 20, 2022 | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL ... | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting i... | Class II | Microgenics Corporation |
| Jan 20, 2022 | ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | LUMBAR PUNCTURE DRUG FREE TRAY 22G | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 20, 2022 | BenchMark ULTRA and DISCOVERY ULTRA Instruments | Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of... | Class II | Ventana Medical Systems Inc |
| Jan 20, 2022 | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular 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.