Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging seal and loss of ster... | Class II | Medline Industries Inc |
| Mar 9, 2020 | Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading t... | Class II | Abbott Gmbh & Co. KG |
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receive... | Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an ... | Class II | Sysmex America, Inc. |
| Mar 9, 2020 | Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect component was used within... | Class II | Radiometer Medical ApS |
| Mar 6, 2020 | Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-... | The printed expiration dates are incorrect. | Class II | Cook Inc. |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Nu... | The printed expiration dates are incorrect. | Class II | Cook Inc. |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready... | The UDI on the device label indicates incorrect manufacturer. | Class III | Linet Americas |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Ra... | The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use... | Class II | R82 A/S |
| Mar 6, 2020 | TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 573... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidan... | No torque was specified for the four screws that connect the gearbox and the mounting flange with... | Class II | Philips North America, LLC |
| Mar 5, 2020 | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service N... | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... | Class II | Philips North America, LLC |
| Mar 5, 2020 | TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System ... | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... | Class II | Philips North America, LLC |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices s intended to be used in the an... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to ... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | The OBM system functional test (impedance and noise) was not carried out on the affected items pr... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Mar 5, 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Solder connection failure on Power Management printed circuit board assembly of ventilators may c... | Class II | Respironics California, LLC |
| Mar 5, 2020 | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single mon... | Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could... | Class II | Skytron, Div. The KMW Group, Inc |
| Mar 4, 2020 | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno... | A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago inst... | Class II | Diagnostica Stago, Inc. |
| Mar 4, 2020 | RayStation standalone software treatment planning system, Model Numbers 4.0, ... | Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtu... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 3, 2020 | Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 -... | It is possible that the collimators have screw hole locations that were insufficiently tapped. T... | Class II | Capintec Inc |
| Mar 2, 2020 | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-defic... | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the ... | Class II | CSL Behring GmbH |
| Mar 2, 2020 | Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients ... | Pinion gear may disengage from track allowing lift to slip or jolt. | Class II | Merits Holdings Co. dba Merits Health Products,... |
| Feb 28, 2020 | Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product U... | Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid inf... | Class II | Smiths Medical ASD Inc. |
| Feb 28, 2020 | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (1... | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | Class III | CooperSurgical, Inc. |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if non-applicable shock ... | Class II | Abbott |
| Feb 28, 2020 | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fi... | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that t... | Class II | Argo Medical Technologies Ltd |
| Feb 27, 2020 | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF ... | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanica... | Class II | DeRoyal Industries 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.