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 |
|---|---|---|---|---|
| Sep 28, 2022 | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA00... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the so... | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, i... | Class II | X-NAV Technologies, LLC |
| Sep 28, 2022 | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Pilling Wecksorb Cylindrical Sponges | Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the a... | Class II | TELEFLEX LLC |
| Sep 28, 2022 | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 | IgA Reagent may start showing cloudiness over time, which can affect assay performance. | Class II | Kamiya Biomedical Company, LLC |
| Sep 27, 2022 | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Us... | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (1... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 23, 2022 | GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (... | GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. | Class II | GAGA PRO LIGHTING EQUIPMENT CO., |
| Sep 23, 2022 | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers wer... | Class III | LumiraDx |
| Sep 22, 2022 | Hamilton-C6 | Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for... | Class II | Hamilton Medical AG |
| Sep 22, 2022 | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100... | Due to increase in Li-Ion Battery failures | Class II | ZOLL Circulation, Inc. |
| Sep 21, 2022 | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | Due to manufacturing records (Release Test Results) indicating "Failed". | Class II | W L Gore & Associates, Inc. |
| Sep 21, 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope... | Class II | MICROVENTION INC. |
| Sep 20, 2022 | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104.... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-7070... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-711... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ... | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may re... | Class II | Ethicon, Inc. |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone ... | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the ... | Class II | Angiodynamics, Inc. |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, R... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Ki... | Product may not be sterile | Class II | TELEFLEX LLC |
| Sep 20, 2022 | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic... | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr... | Class II | Intuitive Surgical, Inc. |
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.