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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
Aug 11, 2021 LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Mo... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 10, 2021 TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 10, 2021 TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend... Software: A coding error associated with the Fast3D Segmentation software. During the scanning p... Class II DePuy Orthopaedics, Inc.
Aug 4, 2021 Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Mac Medical Supply Co Inc
Jul 28, 2021 Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model number... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbe... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number ... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 1, 2021 ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl... Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a re... Class II DePuy Orthopaedics, Inc.
Jun 24, 2021 cobas infinity central lab running software version 3.01.03 through 3.02.08, ... Under specific circumstances created by the user, the cobas e flow test results could be replaced... Class II Roche Diagnostics Operations, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Ite... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
May 28, 2021 Affinity Four Birthing Bed-used as a birthing bed for women of child bearing ... Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it cou... 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.