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.

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DateProductReasonClassFirm
Jan 15, 2020 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Pro... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Pr... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Cathe... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 14, 2020 Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used ... Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... Class II Medtronic CoreValve LLC
Jan 14, 2020 Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p... Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... Class II Medtronic CoreValve LLC
Jan 14, 2020 Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips H... M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid ... Class II Philips North America, LLC
Jan 14, 2020 i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Pro... Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient ... Class II Abbott Point Of Care Inc.
Jan 14, 2020 BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 i... The filter installed onto the tube set may have the incorrect pore size. Class II CME America, LLC
Jan 14, 2020 Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... The bracket torque was mislabeled on the packaging. Class II Ormco/Sybronendo
Jan 13, 2020 DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - ... The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. Class II Mindray DS USA, Inc. dba Mindray North America
Jan 13, 2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,... There is a potential for the device packaging to become compromised; thus, the sterility of the d... Class II TELEFLEX MEDICAL INC
Jan 13, 2020 Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydro... Incorrect power of lenses than the expected Class II CooperVision Inc.
Jan 13, 2020 The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing s... Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device whic... Class II C.R. Bard Inc
Jan 13, 2020 Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 There is a potential for the device packaging to become compromised; thus, the sterility of the d... Class II TELEFLEX MEDICAL INC
Jan 13, 2020 Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... Class II Philips North America, LLC
Jan 13, 2020 Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydro... Incorrect power of lenses than the expected Class II CooperVision Inc.
Jan 12, 2020 Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the ... Class II Siemens Healthcare Diagnostics, Inc.
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 2XLARGE, Gown. Item Code 9578 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health

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.