Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2021 | Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Cat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Cathe... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Cathe... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 4, 2021 | Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Mac Medical Supply Co Inc |
| Jul 29, 2021 | ECHELON Oval MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... | Class III | Sentinel CH SpA |
| Jul 22, 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET... | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirm... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2021 | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex... | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed... | Class II | Baxter Healthcare Corporation |
| Jul 21, 2021 | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | MPR Slotted Mallet, labeling etched onto devices as follows: Medical Prod... | Potential for mallet head to become separated from mallet handle. There is also significant defo... | Class II | Implant Resource Inc |
| Jul 20, 2021 | FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: ... | Due to product complaints received for false negative results (dropouts) with blood culture ident... | Class II | BioFire Diagnostics, LLC |
| Jul 16, 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 Y... | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy... | Class II | Philips North America LLC |
| 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 |
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.