Browse Device Recalls

184 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 184 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 184 FDA device recalls.

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DateProductReasonClassFirm
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Jul 8, 2025 The Medline General Surgery Tray is customized to meet requirements of the ho... Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 24, 2022 Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in cra... There is a potential for the core diameter to be undersized, which may lead to the router breakin... Class II Stryker Instruments
Jun 15, 2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... Class II Stryker Instruments Div. of Stryker Corporation
Oct 16, 2020 Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, si... Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to... Class II Stryker Instruments Div. of Stryker Corporation
Sep 11, 2020 Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Mar 26, 2020 Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Us... Due to a distribution error, product from the affected lot was shipped expired. Class II Stryker Instruments Div. of Stryker Corporation
Jan 22, 2020 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker Corporation
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker Corporation
Jul 31, 2019 C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker Corporation
Jul 31, 2019 C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker Corporation
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
Dec 4, 2018 Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... Class III Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker 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.