Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 29, 2022 | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | Class II | Biomet, Inc. |
| Dec 29, 2022 | (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | Class II | Biomet, Inc. |
| Dec 27, 2022 | MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Con... | Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor vis... | Class II | CooperVision, Inc. |
| Dec 27, 2022 | (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per ca... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 27, 2022 | Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits p... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 27, 2022 | (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD ... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2022 | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lat... | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 23, 2022 | CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 | The kit contained an expired component. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2022 | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/M... | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 23, 2022 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Dec 23, 2022 | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set wi... | Delivery Sets may have tubing that could become detached that could result in patient infection. | Class II | Quest Medical, Inc. |
| Dec 22, 2022 | AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... | Class II | SunMed Holdings, LLC |
| Dec 22, 2022 | EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... | Class II | Encore Medical, LP |
| Dec 22, 2022 | MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF M... | The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 22, 2022 | MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 | The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 22, 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 22, 2022 | Hemopro 2 with Vasoshield, Model VH-4001 | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t... | Class II | Maquet Cardiovascular, LLC |
| Dec 22, 2022 | Vasoshield Syringe Packs, Model VH-5001 | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t... | Class II | Maquet Cardiovascular, LLC |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... | Label with the incorrect component listed on the inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 22, 2022 | Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ... | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 22, 2022 | RipCord Syndesmosis Button, REF: STA001K | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft... | Class II | TriMed Inc. |
| Dec 22, 2022 | Getinge Flow-c Anesthesia System, Part No. 6887700 | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 22, 2022 | MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 | The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 22, 2022 | Getinge Flow-e Anesthesia System, Part No. 6887900 | Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... | Class I | Getinge Usa Sales Inc |
| Dec 22, 2022 | ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno... | Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 22, 2022 | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis... | An increase in the reported complaint rate for inability to deploy was identified and related to ... | Class II | Bard Peripheral Vascular Inc |
| Dec 22, 2022 | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... | Class II | SunMed Holdings, LLC |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... | Product Mislabeled on the outer bag and inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 21, 2022 | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/... | The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... | Class II | Roche Molecular Systems, Inc. |
| Dec 21, 2022 | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test ... | The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... | Class II | Roche Molecular Systems, Inc. |
| Dec 21, 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t... | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o... | Class II | Olympus Corporation of the Americas |
| Dec 21, 2022 | Luminos dRF with software VD10- A diagnostic imaging system for radiographic... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the... | The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... | Class II | Roche Molecular Systems, Inc. |
| Dec 21, 2022 | Luminos Agile with software VC10 - A diagnostic imaging system for radiograp... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system f... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 20, 2022 | CustomEyes kits | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | Ultracell Wick with 80cc Collection Bag, 20/box | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX | The product may be shorter than packaging indicates | Class II | Bolton Medical Inc. |
| Dec 20, 2022 | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | The product may be shorter than packaging indicates | Class II | Bolton Medical Inc. |
| Dec 19, 2022 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... | Class I | Datascope Corp. |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 D... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size... | All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measur... | Class II | Depuy Ireland UC |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected w... | A software bug eliminated the initial ECG activation and review of the ECG under a physician. How... | Class II | Withings |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / D... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... | Class I | Datascope Corp. |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ G... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 /... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
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.