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 |
|---|---|---|---|---|
| Jan 20, 2022 | The Sight OLO device is a computer vision based platform for blood analysis. ... | In instances where custom reference ranges were configured on the device post installation, a po... | Class II | SIGHT DIAGNOSTICS LTD |
| Jan 20, 2022 | SAFE-T PLUS ATRAUMATIC ADULT LP TRAY | 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 PEDIATRIC 21G 2.5 | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Bard Peripheral Vascular Inc |
| Jan 20, 2022 | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for cur... | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. | Class II | Envisiontec US Llc |
| Jan 20, 2022 | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 19, 2022 | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model:... | The clip store function in the ultrasound imaging system does not work when the system has a disk... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 19, 2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedura... | Class II | Volcano Corporation |
| Jan 18, 2022 | LINQ II Insertable Cardiac Monitor | Devices may lose functionality due to susceptibility to moisture ingress. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 18, 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | Class II | Merete Medical GmbH |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... | individual components have been labelled with incorrect colours. The red and green colours are op... | Class II | Cytocell Ltd. |
| Jan 17, 2022 | OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE,... | The sterile pouch seal may contain channels that could affect the seal integrity and potentially ... | Class II | Lacrimedics Inc |
| Jan 17, 2022 | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE... | The sterile pouch seal may contain channels that could affect the seal integrity and potentially ... | Class II | Lacrimedics Inc |
| Jan 14, 2022 | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6... | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ... | Class II | Maquet Cardiovascular, LLC |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 14, 2022 | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | Optic nerve head angiography scan to be turned off due to its distribution without pre-market cle... | Class II | Carl Zeiss Meditec, Inc. |
| Jan 14, 2022 | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general l... | A software defect in the camera control unit (CCU) will cause the image on the monitor to flip up... | Class II | Stryker Corporation |
| Jan 14, 2022 | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead l... | Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate i... | Class II | Hill-Rom, Inc. |
| Jan 14, 2022 | BUTLER Clear Dip, 12 bottles/case | Product lacks premarket clearance. | Class II | Sunstar Americas, Inc. |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 13, 2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone ... | During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... | Class II | Nextremity Solutions |
| Jan 13, 2022 | Everest MI XT Outer Dilator, Catalog Number 5101-90168 | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not ... | Class II | K2M, Inc |
| Jan 13, 2022 | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone r... | During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... | Class II | Nextremity Solutions |
| Jan 13, 2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | Products are mislabeled with the incorrect product identification on individual kit labeling. | Class II | ROi CPS LLC |
| Jan 13, 2022 | Everest MI XT Inner Dilator, Catalog Number 5101-90167 | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not ... | Class II | K2M, Inc |
| Jan 13, 2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad... | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Class III | Physio-Control, Inc. |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containi... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (fin... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/... | Retinal analysis system software has some features, based on artificial intelligence, that potent... | Class II | Diagnos Inc |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 10, 2022 | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLE... | Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries,... | Class II | Compass Health Brands (Corporate Office) |
| Jan 10, 2022 | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD ... | There are lower than expected MICs for some gram negative species. | Class II | Remel Inc |
| Jan 10, 2022 | RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component... | The product does not have 510(k) clearance. | Class I | BASE 10 GENETICS INC |
| Jan 10, 2022 | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 9, 2022 | Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked | Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S... | Class II | Acon Biotech (Hangzhou) Co., Ltd. |
| Jan 7, 2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM ... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | The product was released for distribution without passing sterilization results, which could pote... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
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.