Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 26, 2016 | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute ... | Dialyzer header leak due to possible improper torque | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Feb 26, 2016 | system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, ... | In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cab... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 26, 2016 | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera syst... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 26, 2016 | Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive... | Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog n... | Class II | Roche Diagnostics Operations, Inc. |
| Feb 26, 2016 | The Symbia gamma camera system Product Usage: The Symbia gamma camera sy... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high... | The firm received a complaint of the battery exploding while recharging. | Class II | Scottcare Corporation |
| Feb 25, 2016 | 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock P... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Dr... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, a... | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS ex... | Class II | Toshiba American Medical Systems Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an ac... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca... | Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a... | Class II | Biomerieux Inc |
| Feb 24, 2016 | Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used ... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Unloader Custom Product Usage: Unloader Custom is an external knee braces... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... | Wrong quantitative results may be displayed in a report from the device, which may potentially le... | Class II | Ab Sciex |
| Feb 24, 2016 | NecLoc Extrication Collar Product Usage: Necloc collars are applied to pa... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Miami J Collar Product Usage: Miami J collars are applied to patients aff... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Extreme Custom Product Usage: Extreme Custom is an external knee braces t... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reo... | Product does not meet sterility requirements based on FDA analysis and tested positive for Bacter... | Class II | Amd Ritmed |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Unloader XT Product Usage: Unloader XT Extreme is an external knee braces... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an acc... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Rebound Cartilage Product Usage: Rebound Cartilage is an external knee br... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an ex... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | syngo X Workplace is a medical workstation for real-time viewing, image manip... | After importing, the segmentation results appear mirrored at the CARTO system and can't be used f... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 24, 2016 | Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose P... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | Unloader Custom Lite Product Usage: Unloader Custom Lite is an external ... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 24, 2016 | PureWick External Catheter for Women-Wick Product Usage: A flexible, con... | PureWick is recalling external catheter for women Wicks because the labeling did not contain the ... | Class II | Purewick Corporation |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for g... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... | Class II | Ossur H / F |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Custom Tubing Packs Custom tubing pack for oxygenators | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 23, 2016 | Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... | Out of specification at the thread. The thread height of these screws is under-sized. The cross s... | Class II | Synthes (USA) Products LLC |
| Feb 23, 2016 | X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical N... | The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with regist... | Class II | X-NAV Technologies, LLC |
| Feb 23, 2016 | Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneo... | Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" P... | Class II | Covidien Medical Products (Shanghai) Manufactur... |
| Feb 23, 2016 | HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 23, 2016 | Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... | Out of specification at the thread. The thread height of these screws is under-sized. The cross s... | Class II | Synthes (USA) Products 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.