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 |
|---|---|---|---|---|
| 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 |
| May 12, 2021 | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, L... | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... | Class II | W L Gore & Associates, Inc. |
| May 12, 2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... | 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 | ComfortGel - assists in the prevention and treatment of all pressure injury s... | 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 | Stretcher Chair-for use in all acute care hospitals and medical outpatient se... | 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 | CUB Pediatric Crib- intended to provide a pediatric patient support surface f... | 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 | Transport Stretcher 747 - a non-powered, wheeled device designed to support 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 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | 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),Thermoelectric Cooling Lid, Model: ... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | InTouch 2131-intended to support a human patient in an acute care setting, M... | 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 | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, L... | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... | Class II | W L Gore & Associates, Inc. |
| May 12, 2021 | Michael Graves with Stryker Highback Chair-intended for pediatric and adult 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 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | 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 | Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... | 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 | Proform- support surface is used to assist in the prevention and treatment of... | 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, Model: MCH-1000(i), CE 2797, UDI: (01)0086... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 7, 2021 | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 6, 2021 | Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS,... | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... | Class II | Corin Ltd |
| May 6, 2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hi... | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... | Class II | Corin Ltd |
| Apr 30, 2021 | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Dispo... | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a pa... | Class II | CooperSurgical, Inc. |
| Apr 26, 2021 | REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 21, 2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ... | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. | Class II | Anodyne Surgical |
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.