Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Sep 30, 2022 BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. 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 MEDLINE LINQ TRAY, REF DYNJ65880A. 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 Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System,... Radio frequency emission from a functioning WatchCare device may potentially impact other devices... Class I Baxter Healthcare Corporation
Sep 30, 2022 BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. 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 BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical pr... 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 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 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 Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... Radio frequency emission from a functioning WatchCare device may potentially impact other devices... Class I Baxter Healthcare Corporation
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 MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in me... 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 MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical proc... 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 MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. 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 Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... Radio frequency emission from a functioning WatchCare device may potentially impact other devices... Class I Baxter Healthcare Corporation
Sep 30, 2022 CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conv... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
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 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 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 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 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 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 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 14, 2022 Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142... Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... Class II Baxter Healthcare Corporation
Sep 14, 2022 Prismaflex M Set: M150 (product code 109990). For use in providing continuo... Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... Class II Baxter Healthcare Corporation
Sep 14, 2022 Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). Fo... Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... Class II Baxter Healthcare Corporation
Sep 14, 2022 Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ... Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... Class II Baxter Healthcare Corporation

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.