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 |
|---|---|---|---|---|
| Nov 29, 2017 | CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This d... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCO... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FE... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LC... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT R... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HA... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM ST... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-C... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/N... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM CO... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicate... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 4... | Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEM... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-R... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, H... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polyme... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 28, 2017 | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen... | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i... | Class II | DePuy Orthopaedics, Inc. |
| Oct 25, 2017 | fastener, fixation, nondegradable, soft tissue | It was identified that the product was not assembled correctly causing the implant shaft to shift... | Class II | Zimmer Biomet, Inc. |
| Oct 25, 2017 | A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Numbe... | The drill guides were manufactured with the incorrect color anodization. | Class II | Zimmer Biomet, Inc. |
| Oct 24, 2017 | Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty ... | Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in... | Class II | Zimmer Biomet, Inc. |
| Oct 19, 2017 | Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the ... | Cook has identified that the affected lots may contain wire guides that were loaded backwards int... | Class II | Cook Inc. |
| Oct 19, 2017 | Percutaneous Gastrojejunostomy Set Product Usage: Intended for the perc... | Cook has identified that the affected lots may contain wire guides that were loaded backwards int... | Class II | Cook Inc. |
| Oct 19, 2017 | Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Inte... | Cook has identified that the affected lots may contain wire guides that were loaded backwards int... | Class II | Cook Inc. |
| Oct 13, 2017 | Newton Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Rosen Curved Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | TFE Coated Curved Newton LLT | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Fixed Core Bentson | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Disposable Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Plus Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Fixed Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Central Venous Catheter Tray | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Whisker Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Left Atrial Catheter Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Double Flexible Tipped Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Femoral Artery Pressure Monitoring Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Cerebral Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Ultra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Movable Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Coons Interventional Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook 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.