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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| May 7, 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an... | Class II | DePuy Orthopaedics, Inc. |
| Apr 30, 2021 | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. ... | (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... | Class II | Nico Corp. |
| Apr 30, 2021 | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt... | Nonconformities were discovered to the engineering specifications for implant plates and screws. | Class II | Wishbone Medical, Inc. |
| Apr 30, 2021 | Myriad-LX Light Source-for delivery of light to the surgical field to enhance... | (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... | Class II | Nico Corp. |
| Apr 26, 2021 | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 031836... | Roche received several complaints regarding increased control recovery and discrepant elevated re... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 19, 2021 | Econocare Plus Waffle Overlay- Intended for use as a medical device to aid i... | Product contamination-a trace amount of dried bodily fluids may expose patients, health care prov... | Class II | EHOB, Inc. |
| Apr 7, 2021 | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intende... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 7, 2021 | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: in... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 26, 2021 | InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product U... | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... | Class II | Nextremity Solutions |
| Mar 26, 2021 | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Us... | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... | Class II | Nextremity Solutions |
| Feb 22, 2021 | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Jan 21, 2021 | Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... | Class II | G & H Wire Company |
| Jan 15, 2021 | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... | Class II | Biomet, Inc. |
| Jan 8, 2021 | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri... | The taper dimensions may be out of specification due to a production issue during the manufacturi... | Class II | DePuy Orthopaedics, Inc. |
| Jan 6, 2021 | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measur... | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpr... | Class II | Roche Diagnostics Operations, 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.