Browse Device Recalls

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
Jan 21, 2020 Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimen... When excessive amounts of urine spills on the rack transport track and reaches the electrical co... Class II Sysmex America, Inc.
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 2XLARGE, Gown. Item Code 9578 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK XLARGE, Gown. Item Code 9548 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK LARGE, Gown. Item Code 9518 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 7, 2020 Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... There is potential for the sterile wrap to become loose while in transit and compromise the steri... Class II Medline Industries Inc
Dec 12, 2019 ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8... Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... Class II Baxter Healthcare Corporation
Dec 12, 2019 Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8... Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... Class II Baxter Healthcare Corporation
Dec 2, 2019 Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The I... Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. Class II Medela Inc
Nov 25, 2019 bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an ele... The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic hig... Class II Vyaire Medical
Nov 18, 2019 BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system... BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than spe... Class II Leica Microsystems, Inc.
Nov 15, 2019 Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L There is the potential presence of particular matter in the header caps of ten lots the Revaclear... Class II Baxter Healthcare Corporation
Oct 30, 2019 Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... Class II Medline Industries 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.