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 |
|---|---|---|---|---|
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An en... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental i... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous denta... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implan... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implan... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Aug 16, 2016 | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro... | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor... | Class II | Zimmer Biomet, Inc. |
| Aug 9, 2016 | Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve ... | Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... | Class II | Zimmer Biomet, Inc. |
| Aug 9, 2016 | Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and O... | Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... | Class II | Zimmer Biomet, Inc. |
| Aug 9, 2016 | Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and... | Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F... | Class II | Zimmer Biomet, Inc. |
| Aug 8, 2016 | Vanguard 360 Revision Knee System Knee prostheses | The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolt... | Class II | Zimmer Biomet, Inc. |
| Aug 8, 2016 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. | Product was incorrectly packaged. | Class II | Biomet 3i, LLC |
| Aug 2, 2016 | Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smoot... | The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and o... | Class II | Zimmer Biomet, Inc. |
| Jul 29, 2016 | ROSA BRAIN 3.0.0 | Non-conforming product label. | Class II | Zimmer Biomet, Inc. |
| Jul 20, 2016 | ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin... | Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. | Class II | Zimmer Biomet, Inc. |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... | Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... | Class II | Zimmer Surgical Inc |
| Jul 1, 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... | Class II | Nidek Inc |
| Jun 30, 2016 | Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled ster... | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... | Class II | Zimmer Biomet Spine, Inc |
| Jun 30, 2016 | Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled ... | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... | Class II | Zimmer Biomet Spine, Inc |
| Jun 27, 2016 | TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes... | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... | Class II | Zimmer Gmbh |
| Jun 27, 2016 | TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill hole... | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... | Class II | Zimmer Gmbh |
| Jun 27, 2016 | V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill ho... | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... | Class II | Zimmer Gmbh |
| Jun 27, 2016 | V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill ho... | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... | Class II | Zimmer Gmbh |
| Jun 13, 2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... | Potential sterility deficiency. | Class II | Biomet Microfixation, LLC |
| Jun 10, 2016 | TSP Hip Fracture Plating System device, fixation, proximal femoral, implant ... | The screw may fracture at the junction of the shaft and the head during implantation. The patient... | Class II | Biomet, Inc. |
| May 27, 2016 | ROSA Brain 3.0 Intended for the spatial positioning and orientation of instr... | Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. | Class II | Zimmer Biomet, Inc. |
| May 11, 2016 | Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Inst... | Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instrument... | Class II | Zimmer Biomet, Inc. |
| Apr 15, 2016 | POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 15, 2016 | 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,2... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 15, 2016 | REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 007010050... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 15, 2016 | TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 15, 2016 | TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 15, 2016 | TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886... | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Apr 11, 2016 | PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to acces... | The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay ... | Class II | Biomet, Inc. |
| Apr 8, 2016 | ROSA Surgical Device 2.5.8 | Potential for software to change the final tool orientation for the command position without comm... | Class II | Zimmer Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. guide, surgical... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Bit, drill. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Passer. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Pin, fixation, ... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Appliance, fixa... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Fastener, fixat... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Plate, fixation... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Reamer. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | 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.