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 |
|---|---|---|---|---|
| Jul 29, 2022 | Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 27, 2022 | Diasol Acid Concentrate REF G100325-10Dex 100 | Due to labeling issue. The box label is different that the gallon label in that gallon label sho... | Class II | Diasol, Inc |
| Jul 27, 2022 | Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Nu... | installation issues | Class II | BARCO NV |
| Jul 27, 2022 | ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP,... | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. | Class II | GELITA MEDICAL GMBH |
| Jul 27, 2022 | 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... | (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, ha... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 27, 2022 | Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... | An incorrect sizing label was applied to the carton packaging. | Class II | Wright Medical Technology, Inc. |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unex... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | Products were released to customers prior to the approval and release of a test report authorizin... | Class II | BALT USA, LLC |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Co... | Acidified Concentrate Distribution System potential electrical safety hazard may result in electr... | Class II | Isopure Corp |
| Jul 26, 2022 | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking age... | Class II | Abbott Laboratories |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | Nobel Biocare N1 TiUltra TCC NP 3.5x13mm | Due to the presence of a burr which may cause an aspiration risk to patient during surgical proce... | Class II | Nobel Biocare |
| Jul 22, 2022 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon... | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... | Class II | Maquet Medical Systems USA |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, RE... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon... | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... | Class II | Maquet Medical Systems USA |
| Jul 22, 2022 | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon... | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... | Class II | Maquet Medical Systems USA |
| Jul 22, 2022 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon... | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... | Class II | Maquet Medical Systems USA |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, ... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEM... | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix ... | Class II | Corin Ltd |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack,... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 22, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 p... | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Class II | Baxter Healthcare Corporation |
| Jul 21, 2022 | Medline CHEST TUBE REORDER NO: DYNJ36762A | Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... | Class II | Medline Industries Inc. |
| Jul 21, 2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... | The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ... | Class II | Unomedical A/S |
| Jul 21, 2022 | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... | Class I | Cardiac Assist, Inc |
| Jul 21, 2022 | Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... | Device does not meet regulatory requirements of stability while stationary, which requires mechan... | Class II | Getinge Usa Sales Inc |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extr... | Class II | bioMerieux, Inc. |
| Jul 20, 2022 | Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... | Ventilators may generate a combination of alarms which may result in loss of communication, techn... | Class I | Getinge Usa Sales Inc |
| Jul 20, 2022 | iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample ... | Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR A... | Class II | Alcor Scientific, Inc. |
| Jul 20, 2022 | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | EVIS EXERA III Bronchovideoscope | The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned t... | Class II | Aizu Olympus Co., Ltd. |
| Jul 19, 2022 | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | Incorrect optical calibration | Class II | Abbott Molecular, Inc. |
| Jul 19, 2022 | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
| Jul 19, 2022 | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
| Jul 19, 2022 | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
| Jul 19, 2022 | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
| Jul 19, 2022 | VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 19, 2022 | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
| Jul 19, 2022 | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... | Class II | Cook Incorporated |
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.