Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jan 26, 2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 This Field Action is being conducted following the identification of a batch mix-up between I.B.S... Class II In2Bones, SAS
Jan 22, 2024 LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 19, 2024 GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catal... Devices without transmural drainage holes may be mislabeled as devices with transmural drainage h... Class II W.L. Gore & Associates, Inc.
Jan 5, 2024 Hemostasis Probe, Model: CD-B622LA The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... Class II Olympus Corporation of the Americas
Jan 3, 2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... The incorrect device is contained in the labeled package. Class II Tornier, Inc
Jan 3, 2024 The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... Class II Quidel Corporation
Jan 2, 2024 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... Class II Zimmer Surgical Inc
Dec 29, 2023 Ingenia Ambition X, Model No. 782109 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 1.5T Conversion, Model No. 781283 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 1.5T, Model No. 781178, 781196, 781296 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Intera 1.5T, Model No. 781195 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 SmartPath to dStream for 1.5T, Model No. 781260, 782112 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 3.0T, Model No. 781177 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 28, 2023 Bubble Sensor (REF: 70105.5720) The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... Class II Maquet Medical Systems USA
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 21, 2023 FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... Class II G & H Wire Company
Dec 20, 2023 These wipes are saturated with 0.65% bleach solution. These wipes are antimic... There is stability concern for products dated with a 24-month shelf life. Product is safe and eff... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 19, 2023 EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac... Class II Boston Scientific Corporation
Dec 13, 2023 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 13, 2023 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 11, 2023 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... Class II Olympus Corporation of the Americas
Dec 4, 2023 Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Dec 4, 2023 Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Nov 30, 2023 Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn... Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dim... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Nov 29, 2023 Custom procedural convenience kits and trays, Othopedic use, labeled as: a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, urological, labeled as: a) U... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) HEAR... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) CENT... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, ear, nose & throat, labeled as:... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 28, 2023 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... Class II Cordis US Corp
Nov 28, 2023 MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... Class II Cordis US Corp
Nov 28, 2023 Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab... Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr... Class II XTANT Medical Holdings, Inc
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ... 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) BREAST PACK, REF DY... 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) Description, REF DYN... 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 and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I 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.