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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
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.
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 11, 2017 TunneLoc Tibial Fixation Device Product Usage: To provide fixation of sof... Gamma sterilization validation testing indicates the sterilization dose for the product may not b... Class II Zimmer Biomet, Inc.
Oct 11, 2017 TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To pro... Gamma sterilization validation testing indicates the sterilization dose for the product may not b... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Flexible Shaft hip and anatomical shoulder instrument used for preparation of... The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Sirus Drill 13mm diameter trauma instrument used for preparation of bone in T... The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arth... The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70... Class II Zimmer Biomet, Inc.
Sep 29, 2017 Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Numb... Knee implant components (tibial bearings) are labeled with the incorrect size. Class II Zimmer Biomet, Inc.
Sep 29, 2017 Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, It... Knee implant components (tibial bearings) are labeled with the incorrect size. Class II Zimmer Biomet, Inc.
Sep 15, 2017 36MM COCR MODULAR HD -6MM One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset ins... Class II Zimmer Biomet, Inc.
Sep 13, 2017 Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-... Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, Inc.
Sep 13, 2017 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument. Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, Inc.
Sep 13, 2017 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, Inc.
Sep 11, 2017 BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and syn... Cut resistant surgical glove liners lack sterility assurance. Class II Zimmer Biomet, Inc.
Sep 7, 2017 The 2nd Assist Knee Positioner Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to ... Class II Zimmer Biomet, Inc.
Aug 28, 2017 Persona Partial Knee System Product Usage: The Persona Partial Knee Syste... Potential for the Persona Partial Knee Impactor Pad to fracture. Class II Zimmer Biomet, Inc.
Aug 25, 2017 AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.... The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... Class II Zimmer Biomet, Inc.
Aug 25, 2017 AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. ... The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... Class II Zimmer Biomet, Inc.
Aug 25, 2017 G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arth... The affected products are labeled and etched as F-44 mm liners; however, the physical products co... Class II Zimmer Biomet, Inc.
Aug 22, 2017 Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant... Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... 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.