Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 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 675 FDA device recalls.

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DateProductReasonClassFirm
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
Apr 29, 2021 HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indica... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated f... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Pr... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Mar 5, 2021 Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... Investigations related to customer complaints received for particulate matter inside of the Surgi... Class II Covidien
Mar 4, 2021 Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascu... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Mar 4, 2021 Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Mar 4, 2021 Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/T... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Feb 26, 2021 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Feb 26, 2021 CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 7, 2021 Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Dec 9, 2020 Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 9... Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile st... Class II Riverpoint Medical, LLC
Nov 23, 2020 Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3... May contain a damaged internal component which could impede staple deployment and result in incom... Class II Covidien Llc
Nov 23, 2020 Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m... May contain a damaged internal component which could impede staple deployment and result in incom... Class II Covidien Llc
Nov 16, 2020 Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... Class II Covidien Llc
Oct 16, 2020 Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... In-house lab observations and customer reports of overheating and/or thermal damage to the batter... Class II Covidien Llc
Sep 25, 2020 Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". ... Potential for the needle to detach from the cartridge after the bottom of the cartridge is twiste... Class II Cardinal Health 200, LLC
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm,... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 -... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Univer... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 12, 2020 Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item... The device staples may not properly form upon application preventing adequate hemostasis. Use of... Class II Covidien, LP
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-3... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, 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.