Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 15, 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... | Class III | Cell Marque Corporation |
| Jul 15, 2021 | Pneupac paraPac plus 300 ventilator kit, REF P300NGB | Two devices were labeled with the same serial number | Class III | Smiths Medical ASD Inc. |
| Jul 12, 2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 9, 2021 | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) ... | Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing ... | Class II | Medtronic Neuromodulation |
| Jul 8, 2021 | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope ... | Class II | Carl Zeiss Meditec, Inc. |
| Jul 1, 2021 | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl... | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a re... | Class II | DePuy Orthopaedics, Inc. |
| Jul 1, 2021 | GlideScope Go Monitors | Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into ... | Class III | Verathon, Inc. |
| Jun 29, 2021 | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis ... | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... | Class II | Exactech, Inc. |
| Jun 29, 2021 | Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip pro... | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... | Class II | Exactech, Inc. |
| Jun 25, 2021 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodonti... | Product label intended for the European community was distributed to the USA market via their US ... | Class II | Straumann USA LLC |
| Jun 25, 2021 | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | Product labeled as Cutting Electrode may contain BIVAP electrode. | Class II | Richard Wolf GmbH |
| Jun 9, 2021 | Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ... | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. | Class II | Cordis Corporation |
| Jun 4, 2021 | Simpleware ScanIP medical software. For transfer of imaging information from... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Jun 4, 2021 | Simpleware ScanIP software. For transfer of imaging information from a medica... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Jun 3, 2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or... | Mislabeled: Labeled on the package as 60mm contains 45mm devices | Class II | Ethicon Endo-Surgery Inc |
| Jun 3, 2021 | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... | Class II | Axonics Modulation Technologies, Inc. |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 27, 2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), C... | The devices have a different inner diameter than the diameter specified on the outer box label. | Class II | Stryker GmbH |
| May 27, 2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), C... | The devices have a different inner diameter than the diameter specified on the outer box label. | Class II | Stryker GmbH |
| May 19, 2021 | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire ... | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires... | Class II | Bard Access Systems Inc. |
| May 14, 2021 | PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Pr... | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may... | Class II | Smiths Medical ASD Inc. |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 12, 2021 | Prime TC-transport chair intended for medical purposes to assist a person in... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Isolibrium Support Surface - support surface assists in the prevention and tr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | TruRize Clinical Chair - support structure that places human occupants in upr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four buil... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Surgistool-intended to support a healthcare professional during surgical proc... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, C... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | IsoGel Air - support surface assists in the prevention and treatment of all p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE ... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, 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.