Browse Device Recalls
1,515 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,515 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 1,515 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM | 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 440MM | 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 11MM X 440MM | 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 11MM 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. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 1, 2017 | Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... | The products being recalled exceeded the weight previously tested leading to a possibility of dam... | Class II | Zimmer Biomet, Inc. |
| Aug 1, 2017 | Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT... | The products being recalled exceeded the weight previously tested leading to a possibility of dam... | Class II | Zimmer Biomet, Inc. |
| Jul 10, 2017 | THREAD RETRIEVAL DRILL REF 2224 | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOC... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, RE... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPI... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, R... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 5, 2017 | Persona Partial Knee System, Size 8, Finishing Guide | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Pa... | Class II | Zimmer Biomet, Inc. |
| Jun 30, 2017 | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Product may contain the presence of melted sterile packaging upon opening. | Class II | Zimmer Biomet, Inc. |
| Jun 30, 2017 | JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty | For soft tissue fixation | Class II | Zimmer Biomet, Inc. |
| Jun 29, 2017 | PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plas... | Device was distributed with the etching missing from the product. | Class II | Zimmer Biomet, Inc. |
| Jun 26, 2017 | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 16, 2017 | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem ... | Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with S... | Class II | Zimmer Biomet, Inc. |
| Jun 12, 2017 | DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE | A raw material anomaly was discovered in four lots of raw material and has the potential to be on... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | ECHO POR FMRL NC 9X125, model # 192009 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER BIOLOXD OPTION HD 32MM, model # 650-1056 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP PRIMARY STEM 8MM MINI, model # 113628 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | OSS CEMENTED IM STEM 12X150, model # 150366 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350838 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... | The design verification for the previous packaging configuration G928 does not cover the 70cm wir... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 0048060... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, It... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item N... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Num... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonste... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Leng... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | 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.