Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2017 | Sundream 12 V tanning bed | The 30 minute maximum tanning time has been reduced to 20 minutes. | Class II | ProSun International, LLC |
| Dec 2, 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ... | Class II | Cyberonics, Inc |
| Dec 1, 2017 | Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa... | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ... | Class III | Mindray DS USA, Inc. dba Mindray North America |
| Dec 1, 2017 | Rotating IV Pole Rotating IV Pole falls under the category classified as... | There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a by... | Class II | Ohmeda Medical |
| Dec 1, 2017 | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | Class II | Stryker Sustainability Solutions |
| Dec 1, 2017 | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... | Incorrect product and/or label. Sizing is labeled incorrectly. | Class II | Mako Surgical Corporation |
| Dec 1, 2017 | ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, S... | There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. | Class II | Elekta, 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 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental 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 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... | Class II | Hologic, 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 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental 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. |
| 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. |
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.