Browse Device Recalls

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 1, 2024 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... Potential for positively biased results due to signal reduction over shelf life. Class II Ortho-Clinical Diagnostics, Inc.
Mar 1, 2024 Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... Class II Magellan Diagnostics, Inc.
Feb 23, 2024 Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2024 HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... Class II Puritan Medical Products Company, Llc
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Feb 20, 2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Product was mislabeled as a Surgical Cap at its dispenser level. Class III O&M HALYARD, INC.
Feb 7, 2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... Class II Beckman Coulter, Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 2, 2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... Pack and pouch label is missing the manufacturing and expiration date. Class II Beaver Visitec International, Inc.
Jan 26, 2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 This Field Action is being conducted following the identification of a batch mix-up between I.B.S... Class II In2Bones, SAS
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

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.