Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for ... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 16, 2019 | EyeBOX Model OCL 02 | A review of the user manual revealed that two precaution statements were missing. | Class II | OCULOGICA |
| Apr 16, 2019 | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alva... | Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II B... | Class II | Zimmer Surgical Inc |
| Apr 16, 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El... | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en... | Class II | Ad-Tech Medical Instrument Corporation |
| Apr 15, 2019 | Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity... | Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designe... | Class II | Abbott Gmbh & Co. KG |
| Apr 15, 2019 | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. | There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Posi... | Class II | Hitachi America, Ltd., Power Systems Division |
| Apr 15, 2019 | CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS... | There is a potential for movement of the Solstice Tilting Head Fixation System during patient set... | Class II | Med Tec Inc |
| Apr 12, 2019 | Posey Connected Twice-As-Tough Cuffs | Not meeting design specifications. | Class II | TIDI PRODUCTS |
| Apr 12, 2019 | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.m... | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... | Class II | Geistlich Pharma North America, Inc. |
| Apr 12, 2019 | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks,... | Gas springs not always replaced within the interval specified. | Class II | Tecan US, Inc. |
| Apr 12, 2019 | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm... | The firm has become aware of a potential problem with their venous and arterial magnetic catheter... | Class II | Bard Peripheral Vascular Inc |
| Apr 12, 2019 | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.m... | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... | Class II | Geistlich Pharma North America, Inc. |
| Apr 12, 2019 | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.... | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... | Class II | Geistlich Pharma North America, Inc. |
| Apr 12, 2019 | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iB... | The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may ... | Class II | OMNIlife science Inc. |
| Apr 11, 2019 | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Apr 11, 2019 | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical ... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage Pure... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 11, 2019 | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B S... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 10, 2019 | MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ10... | BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of... | Class II | Becton Dickinson & Company |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| Apr 10, 2019 | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgica... | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instrume... | Class II | Uromedica Inc. |
| Apr 9, 2019 | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Ar... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 7084535704... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Apr 9, 2019 | ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Apr 9, 2019 | Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 | Affected products may have been manufactured with the catheter distal end hole too small | Class II | Cook Inc. |
| Apr 9, 2019 | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vial... | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result... | Class II | QUIDEL CARDIOVASCULAR INC |
| Apr 9, 2019 | Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 | Affected products may have been manufactured with the catheter distal end hole too small | Class II | Cook Inc. |
| Apr 9, 2019 | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
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.