Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 30, 2022 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem... | The tibial tray lock detail is oversized (larger than specification). | Class II | Wright Medical Technology, Inc. |
| Sep 30, 2022 | BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used i... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon ... | Three lots tied by two trainees were released without performing the required pull test. If tied ... | Class II | LeMaitre Vascular, Inc. |
| Sep 30, 2022 | BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgic... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem... | The tibial tray lock detail is oversized (larger than specification). | Class II | Wright Medical Technology, Inc. |
| Sep 30, 2022 | MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which ma... | Incorrect configuration of the blades in the package. The blades curve to the right instead of cu... | Class II | Beaver Visitec International, Inc. |
| Sep 30, 2022 | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 29, 2022 | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI... | After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter... | Class II | Canon Medical System, USA, INC. |
| 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 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 | 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 HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | 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, LARGE, Cat. 80104 | 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 | biokitHSV-2 Rapid Test, REF: 300028001 | HSV-2 rapid test may report false positive results. | Class II | Biokit, S.A. |
| Sep 28, 2022 | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLO... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| 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 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 | 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 | 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 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 | 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 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 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 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 | 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 | 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 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 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 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 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 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 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 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) 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 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 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) 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 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) 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) 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 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 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 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 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 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 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 21, 2022 | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | Due to manufacturing records (Release Test Results) indicating "Failed". | Class II | W L Gore & Associates, 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.