Browse Device Recalls
3,164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,164 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 3,164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2017 | Newport Coast Basic Pack, part number 007484-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Setup Tray, part number AMS6414 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | HSG Pack, part number PSS3287 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparoscopy Pack (1184), part number AMS6562 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Total Hip Pack, part number PSS2956 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Kit, part number PHC1307(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Transvaginal Pack, part number CMP1767 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Knee Pack, part number AMS4211 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Orbitofacial Pack, part number AMS5850(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Ortho Pack, part number PSS3466(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Pack (1345), part number AMS6565 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Surgical Pack, part number PSS3540(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Minor/General/Ortho Pack, part number PSS3258(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | General Surgery Pack, part number PSS1380(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Upper Torso Tray, part number PSS1554(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Nasal Pack, part number PSS2186 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 6, 2017 | Color contact lenses labeled under the following brands: Diamond, Fierce, Amb... | Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot number... | Class II | The See Clear Company |
| Jan 3, 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Stryker Leibinger GmbH & Co. KG |
| Jan 3, 2017 | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Stryker Leibinger GmbH & Co. KG |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm D... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm D... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm D... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 28, 2016 | Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dis... | Product sterility compromised due to breach of sterile barrier | Class II | Medtronic Advanced Energy, LLC |
| Dec 14, 2016 | 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 7, 2016 | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... | Damaged packaging, lack of sterility assurance | Class II | Medacta Usa Inc |
| Dec 2, 2016 | RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical... | Lack of sterility assurance | Class II | Biom'up |
| Nov 18, 2016 | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medica... | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | Class II | Teleflex Medical |
| Nov 8, 2016 | SWANSON FINGER JOINT #2, Part Number 4700002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number ... | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow On... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Ar... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, 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.