Browse Device Recalls
3,282 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,282 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 3,282 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 2, 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... | This recall has been identified due to the batch being mislabeled, with the packaged component's... | Class II | Signature Orthopedics Pty Limited |
| Jan 25, 2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... | The recalled products were shipped without the required temperature control packaging, therefore ... | Class II | Stryker Corporation |
| Jan 3, 2018 | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | A probable mislabeling of the product: a different-sized product is referenced on the product pac... | Class II | GETINGE US SALES LLC |
| Dec 20, 2017 | Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... | Medtronic is initiating a voluntary recall because the products identified above did not adequate... | Class II | Medtronic Neurosurgery |
| Dec 11, 2017 | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 | Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ... | Class II | Smith & Nephew, 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. |
| 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. |
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.