Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 18, 2019 | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 D... | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or o... | Class II | Tornier, Inc |
| Oct 11, 2019 | Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex M... | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical... | Class II | TELEFLEX MEDICAL INC |
| Oct 11, 2019 | Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex M... | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical... | Class II | TELEFLEX MEDICAL INC |
| Oct 11, 2019 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... | Class II | AMD Medicom Inc. |
| Oct 11, 2019 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... | Class II | AMD Medicom Inc. |
| Oct 10, 2019 | SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 472358... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item N... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 3285... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 3... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 010055... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| 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. |
| Oct 9, 2019 | Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V A... | The firm has identified that packaging containing components of the hip replacement range are mi... | Class II | Signature Orthopaedics Europe Ltd |
| Oct 8, 2019 | Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P... | The safety cap attached to needles within the needle sets may become dislodged exposing the needl... | Class II | Teleflex Medical |
| Oct 8, 2019 | Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P... | The safety cap attached to needles within the needle sets may become dislodged exposing the needl... | Class II | Teleflex Medical |
| Oct 8, 2019 | Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P... | The safety cap attached to needles within the needle sets may become dislodged exposing the needl... | Class II | Teleflex Medical |
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.