Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 16, 2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, L... | US-dates between the product package label and the bar code display. | Class II | Hager & Meisinger Gmbh |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Produc... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 14, 2020 | Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ... | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... | Class II | Olympus Corporation of the Americas |
| Jul 14, 2020 | Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement... | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... | Class II | Olympus Corporation of the Americas |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1... | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | DNA Genotek Inc. |
| Jun 23, 2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electro... | The label on the cardbox and the blister show the correct symbols for sterilization using irradia... | Class II | Sutter Medizintechnik GmbH |
| Jun 18, 2020 | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rub... | Class II | Mueller Sports Medicine, Inc |
| Jun 18, 2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm s... | Class II | Synthes, Inc. |
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 3, 2020 | PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3,... | The tubes may have been delivered to some users without labels. Users may not be able to identify... | Class II | LONGHORN VACCINES AND DIAGNOSTIC |
| Jun 3, 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Len... | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicati... | Class II | CooperSurgical, Inc. |
| May 19, 2020 | Isolation Droplet Bundle Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 19, 2020 | Respirator Crash Cart Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 15, 2020 | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Us... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 15, 2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II | TeDan Surgical Innovations LLC |
| May 14, 2020 | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - ... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 14, 2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) -... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 14, 2020 | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) -... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 11, 2020 | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Pr... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... | Class II | Radiometer Medical ApS |
| May 11, 2020 | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... | Class II | Radiometer Medical ApS |
| Apr 30, 2020 | DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS | Incorrect labeling of dialysate concentration for hemodialysis. | Class II | Diasol, Inc |
| Apr 24, 2020 | Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for ... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for In... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for In... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Inser... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Ins... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Ins... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert L... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for I... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Ins... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Ins... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 | XXX | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA 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.