Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2020 | RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCA... | The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/... | Class II | GE Healthcare, LLC |
| May 18, 2020 | RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiat... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiat... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radi... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radia... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 15, 2020 | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SM... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| May 15, 2020 | (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | MEVION S250i, MEVION S250; Proton Radiation Treatment System | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correctio... | Class II | Mevion Medical Systems, Inc. |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Us... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #1... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| May 15, 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Materia... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is... | Failures were found in the temperature measurement function while in the predict mode. | Class II | Mediana Co., Ltd. |
| May 15, 2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 14, 2020 | Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Ite... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - ... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 14, 2020 | A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 14... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Ite... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number:... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number:... | Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of ... | Class II | Bound Tree Medical |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) -... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 -... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item ... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Nu... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Ite... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90M... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Numbe... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 11001... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) -... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 12, 2020 | Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. | There is a potential to generate incorrect patient results for the following assays: Alkaline Pho... | Class II | Abbott Gmbh & Co. KG |
| May 12, 2020 | Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 | The strike plate fractured off from the forceps inserter devices with minimal impaction or force ... | Class II | XTANT Medical |
| May 12, 2020 | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
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.