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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Mar 9, 2022 RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... Potential for patient data mismatch when using browser "back" button to navigate between patients... Class II Roche Diabetes Care, Inc.
Feb 21, 2022 Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... Class II Freudenberg Medical, Llc
Feb 21, 2022 Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... Class II Freudenberg Medical, Llc
Feb 14, 2022 Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 14, 2022 BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Jan 14, 2022 (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead l... Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate i... Class II Hill-Rom, Inc.
Jan 13, 2022 Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone ... During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... Class II Nextremity Solutions
Jan 13, 2022 Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone r... During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... Class II Nextremity Solutions
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Siz... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pla... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 5, 2022 ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in t... May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to... Class II DePuy Orthopaedics, Inc.
Jan 5, 2022 ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component ... May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to... Class II DePuy Orthopaedics, Inc.
Dec 23, 2021 Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Mo... Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class II Hill-Rom, Inc.
Dec 23, 2021 Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Mode... Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class II Hill-Rom, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Dec 7, 2021 GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 Stems may have an undersized spigot bore diameter therefore separating the proximal body from the... Class II DePuy Orthopaedics, Inc.
Nov 12, 2021 Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38... Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... Class II Cook Inc.
Nov 12, 2021 Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-... Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... Class II Cook Inc.
Oct 18, 2021 Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 6... A potential risk for false negative nitrite results exists when endogenous creatinine levels are ... Class II Roche Diagnostics Operations, Inc.
Oct 13, 2021 Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. R... Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior... Class II Cook Inc.
Oct 8, 2021 Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G0236... Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not... Class II Cook Inc.
Oct 8, 2021 Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Co... Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not... Class II Cook Inc.
Sep 28, 2021 Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G0990... Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ... Class II Cook Inc.
Sep 28, 2021 Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.... Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ... Class II Cook Inc.
Sep 9, 2021 ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacem... Packaging may include screws that are not intended to be used with the 5mm augments, may cause de... Class II DePuy Orthopaedics, Inc.
Aug 11, 2021 OctoStretch with Stretch Leveller - The combination of this products allows t... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 FlexoStretch Model Number: 3156057 - The combination of this products allows ... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 Stretch Leveller Model Number: 3156200 - The combination of this products all... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 LikoStretch 1900 Model Number: 3156051 - The combination of this products all... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, 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.