Browse Device Recalls
1,677 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,677 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 1,677 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 12, 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF... | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle... | Class II | MEDTRONIC ATS MEDICAL, INC. |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, b... | Class II | Microbiologics Inc |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain t... | Class II | Microbiologics Inc |
| Oct 8, 2020 | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) | The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil... | Class III | Microbiologics Inc |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain t... | Class II | Microbiologics Inc |
| Oct 8, 2020 | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage... | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | Class II | Microbiologics Inc |
| Oct 1, 2020 | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49... | Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. | Class II | Microbiologics Inc |
| Oct 1, 2020 | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co... | Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. | Class II | Microbiologics Inc |
| Oct 1, 2020 | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa... | Potential contamination with S. epidermidis E. coli and S. warneri. | Class II | Microbiologics Inc |
| Sep 22, 2020 | Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI... | There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ... | Class II | Boston Scientific Corporation |
| Sep 15, 2020 | 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to... | Corrosion could cause performance failures in the product. | Class II | 3M Company - Health Care Business |
| Sep 15, 2020 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... | Corrosion could cause performance failures in the product. | Class II | 3M Company - Health Care Business |
| Sep 15, 2020 | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b... | Corrosion could cause performance failures in the product. | Class II | 3M Company - Health Care Business |
| Sep 15, 2020 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... | Corrosion could cause performance failures in the product. | Class II | 3M Company - Health Care Business |
| Sep 15, 2020 | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b... | Corrosion could cause performance failures in the product. | Class II | 3M Company - Health Care Business |
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Aug 31, 2020 | Langston Dual Lumen Catheter | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Aug 28, 2020 | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to... | Label has the incorrect size for the tracheotomy tube. | Class II | Smiths Medical ASD Inc. |
| Aug 26, 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | Class II | ev3 Inc. |
| Jul 17, 2020 | Restore Clinician Programmer Application Software, model number A71100, used... | The original version of the A71100 Restore Clinician Programmer Application has been identified t... | Class II | Medtronic Neuromodulation |
| Jul 17, 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | Class II | Diasorin Inc. |
| Jul 14, 2020 | CADD Administration Sets, Model #21-7346-24 | Product may have been manufactured with an air filter assembled in an incorrect orientation. | Class II | Smiths Medical ASD Inc. |
| Jul 13, 2020 | Medtronic SynchroMed, Model A10 | The previous software application version (1.1.300) is missing a decimal separator (a comma) for ... | Class II | Medtronic Inc. |
| Jun 26, 2020 | Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 26, 2020 | Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, ... | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 11, 2020 | PORT-A-CATH¿ II POWER P.A.C. Low Profile" system. | Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System ... | Class II | Smiths Medical ASD Inc. |
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S DR MRI, Model Number W3DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Patient Connector, Model Number 24967 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 26, 2020 | Pediatric Adjustable Flange Tracheostomy Tube Cuffless | One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes wa... | Class II | Smiths Medical ASD Inc. |
| May 22, 2020 | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 ... | High rate of reported complaints for the loss of contact force information while using the TactiC... | Class II | Abbott |
| Mar 24, 2020 | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ... | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ... | Class I | Smiths Medical ASD Inc. |
| Mar 16, 2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Mar 10, 2020 | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pre... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model ... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Mode... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD 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.