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Browse Device Recalls

186 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 186 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 186 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
May 10, 2024 Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a compone... The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... Class II Beaver Visitec International, Inc.
May 10, 2024 Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227 The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... Class II Beaver Visitec International, Inc.
Feb 2, 2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... Pack and pouch label is missing the manufacturing and expiration date. Class II Beaver Visitec International, Inc.
Oct 10, 2023 Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025 One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly cont... Class II Beaver Visitec International, Inc.
Aug 25, 2023 Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. Class II Beaver Visitec International, Inc.
Mar 17, 2023 CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. ... Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permane... Class II Beaver Visitec International, Inc.
Dec 20, 2022 CustomEyes kits Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Dec 20, 2022 Ultracell Wick with 80cc Collection Bag, 20/box Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Nov 30, 2022 Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... Class II Beaver Visitec International, Inc.
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.
Apr 26, 2022 BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Oct 8, 2021 bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cat... Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... Class II Beaver Visitec International, Inc.
Oct 8, 2021 bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xsta... Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... Class II Beaver Visitec International, Inc.
Oct 8, 2021 Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or c... Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... Class II Beaver Visitec International, Inc.
Oct 8, 2021 bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surg... Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... Class II Beaver Visitec International, Inc.
Mar 12, 2019 Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... Class II Beaver Visitec
Feb 19, 2019 Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm... The product contains a misprinted expiration date on the peel pack. Both were printed as "180615... Class III Beaver Visitec
Nov 30, 2018 BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Sof... Certain lots are missing a protective sheath component over the silicone tip, which may result in... Class II Beaver Visitec
Jul 19, 2018 Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model ... A small number of devices in this lot may have a melted cap and a hole formed through the packagi... Class II Beaver Visitec
Jun 18, 2018 Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmi... Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the ... Class II Beaver Visitec
May 14, 2018 Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to m... Blades are loose in handles and may fall out due to non cured epoxy Class II Beaver Visitec

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.