Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 23, 2020 | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Numb... | Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not perfor... | Class II | Remel Europe Ltd. |
| Jul 22, 2020 | CombiDiagnost R90 Software Version R1.0 and R1.1 | Philips has become aware of a software issue, where the kV and mA values are not locked immediate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jul 22, 2020 | POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 008855565... | Multiple lots being recalled due to a product design issue | Class II | Smith & Nephew Orthopaedics AG |
| Jul 21, 2020 | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is ... | Modular Junction Box (MJB) cables can melt and affect the bed functionality. | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Jul 20, 2020 | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Us... | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant me... | Class II | NOBEL BIOCARE SERVICES AG |
| Jul 17, 2020 | Match Point System The Match Point System is intended to by uses as a surg... | The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly i... | Class II | Materialise N.V. |
| Jul 17, 2020 | Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p... | A low risk of a false positive result being issued with a laboratory developed test (LDT) that ut... | Class II | Cytocell Ltd. |
| Jul 17, 2020 | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Pl... | IBA became aware of an issue to resume aborted irradiations because the plan to complete the trea... | Class II | Ion Beam Applications S.A. |
| Jul 16, 2020 | uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is inte... | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts;... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 16, 2020 | Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 16, 2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 16, 2020 | uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is in... | 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Poten... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 16, 2020 | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Jul 16, 2020 | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Jul 10, 2020 | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked... | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... | Class II | RANDOX LABORATORIES, LTD. |
| Jul 10, 2020 | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... | Class II | RANDOX LABORATORIES, LTD. |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1... | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | DNA Genotek Inc. |
| Jun 23, 2020 | TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact... | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact le... | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | Neurosign V4 Intraoperative Nerve monitor family of devices. | Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and... | Class II | The Magstim Company Limited |
| Jun 23, 2020 | TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 22, 2020 | CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usa... | Software defect may result in disapperance of tag sites during recalculation and lead to addition... | Class II | Biosense Webster (israel), Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 19, 2020 | Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... | Quality Control results were not properly evaluated for QC failures. | Class II | Abbott Gmbh & Co. KG |
| Jun 17, 2020 | LoFric Origo, Nelaton, 16in, FR10 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | LoFric Origo, Tiemann, 16in, FR14 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | LoFric Origo, Tiemann, 16in, FR12 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA ... | The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman C... | Class II | Beckman Coulter Biomedical GmbH |
| Jun 16, 2020 | MatrixMIDFACE Screws - Product Usage: The intended use for this device is in ... | One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a bo... | Class II | Synthes Produktions GmbH |
| Jun 10, 2020 | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may ... | Class II | Elekta Instrument AB |
| Jun 8, 2020 | Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPr... | The motor controller may fail, which can potentially lead to an error in functionality of the Bod... | Class II | Hocoma AG |
| Jun 5, 2020 | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) com... | Tube material of a smaller diameter was used. | Class II | Richard Wolf GmbH |
| May 26, 2020 | RayStation standalone software treatment planning system (RayStation 8A, 8B, ... | It is not obvious that the manual import of a treatment record into RayCare PACS does not automat... | Class II | RAYSEARCH LABORATORIES AB |
| May 26, 2020 | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPIN... | 6.0x50mm poly-reduction screws were laser etched 6.0x45 | Class II | U&I CORP. |
| May 23, 2020 | Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 In... | Two issues were identified with the computed tomography x-ray system including a service function... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 21, 2020 | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, ... | In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there ca... | Class II | Elekta Limited |
| May 18, 2020 | RayStation 8B Service Pack 1, UDI # 07350002010204 - 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 1, UDI #s 07350002010037, 07350002010082 - Produ... | 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 9B, UDI # 07350002010266 - 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 6, UDI # 07350002010013 - Product Usage: For radiation therapy and... | 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 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation ... | 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 8B Service Pack 2, UDI # 07350002010235 - 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 7, UDI # 07350002010068 - Product Usage: For radiation therapy an... | 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, UDI # 07350002010112 - Product Usage: For radiation therapy an... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
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.