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Browse Device Recalls

812 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 812 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 812 FDA device recalls in PR.

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DateProductReasonClassFirm
Aug 15, 2025 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX S... Potential for barb non-engagement. Class II ETHICON, LLC
Mar 7, 2025 PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 Identified curing issues with the silicone during the needles manufacturing process. Class II Ethicon Endo Surgery, LLC
Mar 7, 2025 ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH Identified curing issues with the silicone during the needles manufacturing process. Class II Ethicon Endo Surgery, LLC
Mar 7, 2025 PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM Identified curing issues with the silicone during the needles manufacturing process. Class II Ethicon Endo Surgery, LLC
Mar 7, 2025 PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP Identified curing issues with the silicone during the needles manufacturing process. Class II Ethicon Endo Surgery, LLC
Dec 20, 2024 PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Sutur... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Dec 20, 2024 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Dec 20, 2024 PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Aug 10, 2023 PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05... Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... Class II ETHICON, LLC
Aug 10, 2023 PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP... Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... Class II ETHICON, LLC
Mar 5, 2021 Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... Investigations related to customer complaints received for particulate matter inside of the Surgi... Class II Covidien
Apr 20, 2017 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal f... Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... Class I EBI Patient Care, Inc.
Apr 20, 2017 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion a... Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... Class I EBI Patient Care, Inc.
Jun 27, 2016 Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Su... After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade c... Class II Aspen Surgical Puerto Rico Corp.
May 4, 2016 Periarticular plating system, cancellous bone screw, partially threaded, hex ... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fu... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Len... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 4... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Len... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabu... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 m... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head,... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical sc... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
May 4, 2016 VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 ... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
Mar 17, 2016 Persona The Personalized Knee System Articular Surface Posterior Stabilized (... The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... Class II Zimmer Manufacturing B.V.
Mar 17, 2016 Persona The Personalized Knee System Articular Surface Posterior Stabilized (... The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 72 consists of all product code: JDI and same usage: Item no: 805... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 24 consists of all product under product code: HRS and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 44 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 23 consists of all product code: JDI and same usage: Item no: 8011... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 21 consists of all product under product code: JDI and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 68 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 61 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 2 consists of all products product code LPH, and same usage: 8018022... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 6 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 55 consists of all product under product code: HSB and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 58 consists of all product under product code: HRS and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 38 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 33 consists of all product under product code: JDI and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 11 consists of all product under product code JDI , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 57 consists of all product code: JDI and same usage: Item no: 7634... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 39 consists of all product under product code: JDI and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 50 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 9 consists of all product under HRS, and same usage: Item no: 4749... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 32 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 41 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 26 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 49 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.

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.