Browse Device Recalls

812 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 812 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 812 FDA device recalls.

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DateProductReasonClassFirm
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS9... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CD... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT,... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY -... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 PVP SOLUTION SING STRL, REF DYNDA1858 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP SLN KIT, REF DYNDM1097 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE STERILE PREP STICK, REF DYNDA1134 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP, REF DYNDA1649 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE BETADINE, REF DYNDA1998 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE POVIDONE, REF DYNDA2061 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP SOLUTION, REF DYNDA1907 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 24 BLOOD CULTURE KIT, REF DYNDH1632 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 BLOOD CULTURE KIT, REF DYNDH1647B This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF DYND12578 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF DYND12574 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF URO12573 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Aug 4, 2023 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... Class I MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the ti... Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 3, 2023 Total Hip Kit, REF DYNJ903275S; surgical convenience kit The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2023 Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST... Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield

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.