Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Mar 6, 2024 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mate... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 3... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, I... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 4... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustmen... Class II Wright Medical Technology, Inc.
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminate... Class II Microbiologics Inc
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; ... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, It... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hou... Class I Outset Medical, Inc.
Mar 6, 2024 Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b)... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mat... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED... The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... Class II Exactech, Inc.
Mar 5, 2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests There are two windows on the test device, the control line window and the test results window. Th... Class II Quidel Corporation
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests There are two windows on the test device, the control line window and the test results window. Th... Class II Quidel Corporation
Mar 5, 2024 DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device use... Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Int... Class II Beckman Coulter, Inc.
Mar 5, 2024 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351... Class II Randox Laboratories Ltd.
Mar 5, 2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... Class I Tandem Diabetes Care, Inc.
Mar 5, 2024 OptiCross Coronary Imaging Catheter, REF H749518080120 Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect vo... Class II Boston Scientific Corporation
Mar 5, 2024 Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended fo... Inconsistencies were identified with service records associated with corrections performed for a ... Class II Baxter Healthcare Corporation
Mar 5, 2024 Neria Soft Infusion Set, Product Code 507302, intravascular administration set Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been ... Class II Unomedical A/S
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 Alinity i Anti-HCV Reagent Kit, List Number 08P0521 Customer complaints were received regarding falsely elevated results for some patient samples. In... Class II Abbott GmbH
Mar 4, 2024 X-Guide Handpiece Adaptor Sleeve 1, Model P010701 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... Class II X-NAV Technologies, LLC
Mar 4, 2024 X-Guide Handpiece Adaptor Sleeve 3, Model P010727 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... Class II X-NAV Technologies, LLC
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 EZ2 Connect MDx-IVD Designed to perform automated isolation and purification ... Insufficient welding leads to the heater cable becoming brittle and present with an error: ERRO... Class II Qiagen Sciences LLC
Mar 4, 2024 IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... There is a risk of mistreatment as irradiation is not prevented when some safety parameters are o... Class II Ion Beam Applications S.A.
Mar 4, 2024 ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Customer complaints were received regarding falsely elevated results for some patient samples. In... Class II Abbott GmbH
Mar 1, 2024 Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle assist system inflow c... Class I Thoratec Corp.
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 Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators use... The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference mat... Class II Randox Laboratories Ltd.
Mar 1, 2024 Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... Class II Olympus Corporation of the Americas
Mar 1, 2024 Mojo Full Face with Headgear, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Phantom 2 Nasal Vented Mask Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation

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.