Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

Clear
DateProductReasonClassFirm
Aug 4, 2020 Alaris System PC Unit Model 8015 The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 Integra Padgett Dermatome Set - Product Usage: are intended for use in the cu... lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... Class II Integra LifeSciences Corp.
Aug 4, 2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assemb... Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress p... Class I CareFusion 303, Inc.
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 Artis zee or Artis Q systems (listed below) - Product Usage: for single and b... Potential exists for the collision supervision not to work properly following loss of the individ... Class II Siemens Medical Solutions USA, Inc
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 Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during sur... The products were improperly heat treated. Class II Smith & Nephew, Inc.
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
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" ... 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 6/0 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 2/0 Undyed 30" V-... 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 6/0 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" 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 6/0 VL 18" P-10... 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 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 0 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 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 0 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 0 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 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" ... 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 DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contai... There is a potential for the retaining pin of the tibial punch handle to become loose and fall ou... Class II Encore Medical, LP
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
Jul 31, 2020 PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics Inc.
Jul 31, 2020 PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descripti... MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium ... Class II MicroPort Orthopedics Inc.
Jul 31, 2020 Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC,... Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. Class II Klarity Medical Products LLC
Jul 31, 2020 PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, ... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics Inc.

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.