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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2019 | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 002348... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 0057... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 002232... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 010029605... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 472... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 4724931801... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | LPS-MOB ART SURF IMPL D 9MM | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various fixation systems and accessories, Item Nos. 00224000916 00224000918 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various fixation systems and accessories, Item Nos. 00118100522 00118100527 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 008... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various temporary devices used during the implantation of the device system: ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 008... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 328554... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Connection Screw for NCB Plate, Item No. 0202266002 | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 004300007... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usa... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Pro... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instru... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 ... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 17... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 ... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMR... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arco... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | Comprehensive RS Cleat CAP, Item No. 110300 | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin ... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product U... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM000009... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | 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.