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 |
|---|---|---|---|---|
| Jul 14, 2017 | PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained ... | Class II | Panoramic Rental Corp. |
| Jul 12, 2017 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... | Class II | DePuy Orthopaedics, Inc. |
| Jul 12, 2017 | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... | Class II | DePuy Orthopaedics, Inc. |
| Jul 5, 2017 | Persona Partial Knee System, Size 8, Finishing Guide | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Pa... | Class II | Zimmer Biomet, Inc. |
| Jul 5, 2017 | Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... | Class II | Roche Diagnostics Corporation |
| Jul 5, 2017 | cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... | Class II | Roche Diagnostics Corporation |
| Jun 30, 2017 | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Product may contain the presence of melted sterile packaging upon opening. | Class II | Zimmer Biomet, Inc. |
| Jun 30, 2017 | JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty | For soft tissue fixation | Class II | Zimmer Biomet, Inc. |
| Jun 29, 2017 | Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... | Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 17... | Class II | Roche Diagnostics Corporation |
| Jun 29, 2017 | PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plas... | Device was distributed with the etching missing from the product. | Class II | Zimmer Biomet, Inc. |
| Jun 16, 2017 | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem ... | Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with S... | Class II | Zimmer Biomet, Inc. |
| Jun 12, 2017 | DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE | A raw material anomaly was discovered in four lots of raw material and has the potential to be on... | Class II | Zimmer Biomet, Inc. |
| Jun 12, 2017 | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... | Class II | Roche Diabetes Care, Inc. |
| Jun 12, 2017 | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... | Class II | Roche Diabetes Care, Inc. |
| Jun 8, 2017 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 8, 2017 | Accu-Chek Connect diabetes management software app, Catalog number 0756246200... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 5, 2017 | ECHO POR FMRL NC 9X125, model # 192009 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER BIOLOXD OPTION HD 32MM, model # 650-1056 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP PRIMARY STEM 8MM MINI, model # 113628 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | OSS CEMENTED IM STEM 12X150, model # 150366 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350838 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 0048060... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, It... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item N... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Num... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonste... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Leng... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Leng... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 0048051... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonst... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item N... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 004806... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 004806... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, 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.