Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative mea... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 25, 2024 | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 | Product has have presence of brown discoloration or substance on the hinge area of the device | Class II | Technomed Europe |
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, Inc. |
| Jul 25, 2024 | Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A | At least two units have been found to be missing a weld. | Class II | Intrinsic Therapeutics, Inc. |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 | Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by ... | Class II | Schiller, Ag |
| Jul 24, 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med... | Class II | ROi CPS LLC |
| Jul 24, 2024 | Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following com... | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO | Class II | TMJ Solutions Inc |
| Jul 24, 2024 | Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the f... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. ... | Affected syringes lack FDA clearance. | Class II | Cypress Medical Products LLC |
| Jul 24, 2024 | Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the f... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... | Class I | Abbott Diabetes Care, Inc. |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not sho... | Class II | GE Healthcare |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | VariSoft Infusion Set, Single Use. | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) brand... | Class II | Unomedical A/S |
| Jul 22, 2024 | Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | SlideView VS200 slide viewer, | A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This... | Class II | EVIDENT SCIENTIFIC INC |
| Jul 22, 2024 | Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 19, 2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System... | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specific... | Class II | Biointellisense Inc. |
| Jul 19, 2024 | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... | Class I | Inari Medical - Oak Canyon |
| Jul 18, 2024 | smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; ... | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility te... | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility... | Class II | Becton Dickinson & Co. |
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.