Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endos... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endo... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Dec 22, 2020 | The EOSedge system may acquire two simultaneous orthogonal planar images for ... | Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been... | Class II | EOS Imaging |
| Dec 22, 2020 | Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2... | Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a... | Class II | Cytocell Ltd. |
| Dec 18, 2020 | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 8811... | Component failures may cause the unit to lose all suction. Users will need to obtain alternate su... | Class II | Laerdal Medical (Suzhou) Co., Ltd. |
| Dec 10, 2020 | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor ... | Device requires the use of an Isolation Transformer in combination with the SDM in home care sett... | Class II | SenTec AG |
| Dec 8, 2020 | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product... | A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without be... | Class II | The Magstim Company Limited |
| Dec 7, 2020 | IOLMaster 700 | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient ... | Class II | Carl Zeiss Meditec AG |
| Dec 2, 2020 | Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)0761236705392... | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date sh... | Class II | Medela AG Medical Technology |
| Nov 19, 2020 | CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Produ... | The expiration date on labeling is incorrect. | Class II | Lidco Ltd |
| Nov 17, 2020 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... | A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 13, 2020 | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determinat... | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... | Class II | Randox Laboratories Ltd. |
| Nov 13, 2020 | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of ... | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... | Class II | Randox Laboratories Ltd. |
| Nov 12, 2020 | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone ... | The product is mislabeled. | Class II | Biocomposites, Ltd. |
| Nov 11, 2020 | RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B... | Two issues were found with the treatment plan report: 1) There may be incorrect information for t... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 6, 2020 | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using... | During system upgrade incorrect comments may be added to existing tests. In such instance: Restin... | Class II | Spacelabs Healthcare, Ltd. |
| Nov 3, 2020 | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SUR... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Bio... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biops... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy ... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Val... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-1... | Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which co... | Class II | NEOSTEO |
| Nov 3, 2020 | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Wa... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleanin... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 3, 2020 | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corp... | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... | Class II | GA HEALTH COMPANY LIMITED |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Produ... | XXX | Class II | Chromsystems Instruments & Chemicals GmbH |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Prod... | XXX | Class II | Chromsystems Instruments & Chemicals GmbH |
| Nov 2, 2020 | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The... | Products do not meet stability criteria and may impact results. | Class II | Chromsystems Instruments & Chemicals GmbH |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Produc... | Products do not meet stability criteria and may impact results. | Class II | Chromsystems Instruments & Chemicals GmbH |
| Oct 29, 2020 | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Produc... | Control lots may not meet stability criteria and could result in increased results of patient sam... | Class II | Chromsystems Instruments & Chemicals GmbH |
| Oct 29, 2020 | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Produ... | Control lots may not meet stability criteria and could result in increased results of patient sam... | Class II | Chromsystems Instruments & Chemicals GmbH |
| Oct 29, 2020 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order N... | Calibrator lots may not meet stability criteria and could result in increased results of patient ... | Class II | Chromsystems Instruments & Chemicals GmbH |
| Oct 27, 2020 | MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspi... | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unint... | Class II | Mani, Inc. - Kiyohara Facility |
| Oct 27, 2020 | MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate o... | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unint... | Class II | Mani, Inc. - Kiyohara Facility |
| Oct 8, 2020 | MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and... | Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band caus... | Class II | Medicrea International |
| Oct 8, 2020 | RayStation standalone software treatment planning system, Model No. 4.0, 4.5,... | If a region of interest (ROI) or point of interest (POI) that is referenced from an imported pla... | Class II | RAYSEARCH LABORATORIES AB |
| Oct 6, 2020 | Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjuncti... | Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS) | Class II | Arjohuntleigh Magog, 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.