Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 21, 2015 | CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking br... | Sterility of the product cannot be assured. | Class II | Civco Medical Instruments Co. Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12... | Sterility of the product cannot be assured. | Class II | Civco Medical Instruments Co. Inc. |
| Sep 29, 2015 | Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. | Class II | Medtronic Inc. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 9, 2015 | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... | B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... | Class II | Intuitive Surgical, Inc. |
| Aug 27, 2015 | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... | Class II | Arrow International Inc |
| Aug 25, 2015 | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for car... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Aug 6, 2015 | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with I... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Strai... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Cur... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions ... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve... | Sterility may be compromised | Class II | Covidien LLC |
| Aug 6, 2015 | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ... | Sterility may be compromised | Class II | Covidien LLC |
| Jul 14, 2015 | Histolock Resection Device, US Endoscopy. An electrosurgical device desig... | The company has determined the sterility cannot be assured for the affected lot. | Class II | US Endoscopy Group Inc |
| Jun 18, 2015 | Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... | Potential defect in the forming of the primary package of the blister that may compromise the ste... | Class II | Argon Medical Devices, Inc |
| Jun 18, 2015 | T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... | Potential defect in the forming of the primary package of the blister that may compromise the ste... | Class II | Argon Medical Devices, Inc |
| Jun 16, 2015 | SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. ... | Lack of sterility assurance. | Class II | Symmetry Surgical, Inc. |
| Jun 2, 2015 | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... | Insufficient seal on the outside packaging, potentially affecting the sterility of the product. | Class II | Alcon Research, Ltd. |
| May 18, 2015 | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5... | Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature an... | Class II | Coreva Health Science LLC |
| May 12, 2015 | T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm ... | Potential breach in sterility | Class II | Vidacare Corporation |
| May 8, 2015 | 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare... | Potential sterility breach in the packaging. | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 8, 2015 | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... | Potential lack of sterility assurance. | Class II | Gyrus Acmi, Incorporated |
| May 8, 2015 | Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... | Potential lack of sterility assurance. | Class II | Gyrus Acmi, Incorporated |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| Apr 30, 2015 | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intend... | Sterility of device maybe compromised | Class II | Smith & Nephew, Inc. |
| Apr 28, 2015 | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vasc... | Possible sterility breach of the outer packaging (pouch) material which may compromise the outsid... | Class II | Covidien LLC |
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.