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Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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DateProductReasonClassFirm
Oct 10, 2019 Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisti... Reagent component included in flu test kit may cause both high background signal in a true negati... Class II Hologic, 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 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents ... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Con... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Conten... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of... Class II Draegar Medical Systems, Inc.
Oct 9, 2019 Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI E... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number... Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedu... Class II Stryker Sustainability Solutions
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... Class II Nextremity Solutions
Oct 9, 2019 Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI E... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: ... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Co... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 8, 2019 Cobas infinity central lab / cobas infinity core license-a Calculator/Data Pr... Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver -... Class II Roche Diagnostics Operations, Inc.
Oct 8, 2019 CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... The connector piece to the PEG tube does not pass over the guidewire. Class II Avanos Medical, Inc.
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 CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... The connector piece to the PEG tube does not pass over the guidewire. Class II Avanos Medical, Inc.
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
Oct 7, 2019 Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to... Class II The Binding Site Group, Ltd.
Oct 7, 2019 LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN In... LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls ... Class II Smith & Nephew, Inc.
Oct 7, 2019 Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usag... Intermittent communication due to inconsistent crimping of connectors onto cables. Class II Edwards Lifesciences, LLC
Oct 7, 2019 NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... There is a remote potential for the sterile packaging of the transseptal guiding sheath to be com... Class II Baylis Medical Company Inc.
Oct 7, 2019 Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue... Walkers within the identified serial range have the potential for the front fork to unscrew itsel... Class II Nova Ortho-Med Inc
Oct 7, 2019 Software versions syngo CT VB20 running on the following Siemens SOMATOM CT ... Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanne... Class II Siemens Medical Solutions USA, Inc
Oct 7, 2019 Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. Class II Implant Direct Sybron Manufacturing LLC
Oct 7, 2019 UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II ... When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is sli... Class II Beckman Coulter, Inc.
Oct 7, 2019 TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-5... There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath t... Class II Baylis Medical Company Inc.
Oct 4, 2019 REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-w... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, ... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hang... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, 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.