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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 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 875 FDA device recalls.

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DateProductReasonClassFirm
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-225... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 12, 2018 Phoenix Nail System, intended for use with an intramedullary nail system for ... Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to repor... Class II Zimmer Biomet, Inc.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, Inc.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, Inc.
Feb 19, 2018 SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-M... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Feb 19, 2018 EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 8005082... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Jan 24, 2018 Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 3... One lot of humeral stem implants do not include the humeral bushing components. Class II Zimmer Biomet, Inc.
Jan 3, 2018 Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UD... Two lots of hip implants are mislabeled. Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ... 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 ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST... 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 125 DEG X 9MM STER TROC NAIL 13... 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 END CAP STER TROC END CAP 5MM STER ... 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 ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ... 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 TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ... 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 180X13X140 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 20, 2017 ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC 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 ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL ... 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 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 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.

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.