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Browse Device Recalls

86 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 86 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 86 FDA device recalls.

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DateProductReasonClassFirm
Dec 26, 2024 regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... There is a potential for the Inline Controller to be using the spring out of specification causin... Class I ROi CPS LLC
Jul 24, 2024 regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med... Class II ROi CPS LLC
Jun 17, 2024 Regard Kit containing the Microtek decanter Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. Class II ROi CPS LLC
Dec 18, 2023 regard Operative LAP, Item Number 800943001; surgical convenience kit Surgical convenience kits were manufactured with a component which was subsequently recalled by N... Class I ROi CPS LLC
Nov 20, 2023 Regard Dressing change kit, Item Number 800026006 ROi CPS manufactured and distributed medical convenience kits with an irrigation solution compone... Class I ROi CPS LLC
Sep 21, 2023 Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular conveni... Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Ins... Class II ROi CPS LLC
Sep 11, 2023 GS0008 2Y - Burn Pack - STL, Item Number 880082025 Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS0101... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS007... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenien... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery conven... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenien... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery ... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery ... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery conve... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery c... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; orth... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho sur... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery c... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery conveni... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 83009900... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery conven... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC

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.