Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2017 | ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nai... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2017 | ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 D... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 19, 2017 | Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Prod... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Nu... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-5... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Numb... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 18, 2017 | Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometr... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 18, 2017 | cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 18, 2017 | c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 mod... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 12, 2017 | PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated fo... | A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no s... | Class II | Zimmer Biomet, Inc. |
| Dec 8, 2017 | Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revisi... | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... | Class II | Zimmer Biomet, Inc. |
| Dec 8, 2017 | Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revisi... | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... | Class II | Zimmer Biomet, Inc. |
| Dec 7, 2017 | 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887... | One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated scr... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160M... | 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 GENDER SOLUTIONS FEMALE (GSF) FEMOR... | 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 1 EXT 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 29, 2017 | CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF 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 | CPT 12/14 COCR SIZE 2 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 29, 2017 | CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT 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 | LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP S... | 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 | ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/... | 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 | NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-K... | 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 | PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT... | 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 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT... | 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-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MIN... | 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 | NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indi... | 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 SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT S... | 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 | ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyart... | 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 | NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for pat... | 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 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-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 | CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis | 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 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, ... | 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 OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS O... | 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 FEM IMPLANT SZ H-R This device is indicated for patients with severe k... | 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 2 EXT 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 29, 2017 | LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device ... | 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 PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MIN... | 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 REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, 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 | PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthri... | 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 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. |
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.