Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Apr 24, 2020 | Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 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 S CONN 3/16X1/8 RDR ANLD24 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 1/4 STRLE 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. |
| Apr 24, 2020 | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF... | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled... | Class II | DeRoyal Industries Inc |
| Apr 24, 2020 | Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Inse... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Vein Irrigation Cannula with blunt tip. ASY VIC, 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 1/2 CONN W/LL STRLE 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. |
| Apr 13, 2020 | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog... | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... | Class II | Philips North America, LLC |
| Apr 13, 2020 | Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c... | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... | Class II | Philips North America, LLC |
| Apr 8, 2020 | Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... | Class II | Argon Medical Devices, Inc |
| Apr 8, 2020 | Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... | Class II | Argon Medical Devices, Inc |
| Apr 8, 2020 | PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... | Class II | Argon Medical Devices, Inc |
| Apr 7, 2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical... | Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screw... | Class II | Innovasis, Inc |
| Apr 6, 2020 | SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, 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.