Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2022 | ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastroi... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal end... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ... | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions f... | Class II | Hologic, Inc |
| Oct 4, 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 3, 2022 | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automate... | Unable to charge the battery pack- battery packs will allow the batteries to be charged if the vo... | Class II | Rebiscan, Inc. |
| Sep 30, 2022 | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which ma... | Incorrect configuration of the blades in the package. The blades curve to the right instead of cu... | Class II | Beaver Visitec International, Inc. |
| Sep 30, 2022 | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon ... | Three lots tied by two trainees were released without performing the required pull test. If tied ... | Class II | LeMaitre Vascular, Inc. |
| Sep 23, 2022 | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers wer... | Class III | LumiraDx |
| Sep 16, 2022 | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop)... | Class II | Fresenius Kabi USA, LLC |
| Sep 8, 2022 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggering an alarm that is ... | Class I | Fresenius Kabi USA, LLC |
| Sep 6, 2022 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This... | Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the... | Class II | Philips North America Llc |
| Aug 19, 2022 | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic has confirmed six reports from customers outside the US where the ventilator became ino... | Class II | Covidien Llc |
| Aug 17, 2022 | Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 | Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, re... | Class II | Associates of Cape Cod, Inc. |
| Aug 11, 2022 | IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)... | An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunog... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 9, 2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate ... | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels ... | Class II | Hologic, Inc |
| 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 12, 2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 10, 2022 | INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantabl... | Higher than expected flow rate. | Class I | Intera Oncology, Inc. |
| Jun 24, 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... | Class II | LumiraDx |
| Jun 24, 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... | Class II | LumiraDx |
| Jun 21, 2022 | AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended ... | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 21, 2022 | AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended... | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 16, 2022 | AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic P... | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 16, 2022 | AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic P... | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 8, 2022 | Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For v... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For va... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. F... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and c... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ch... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vasc... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 7, 2022 | TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet t... | Electrical component failure within the control unit. The observed failure mode is a loss of func... | Class II | Covidien Llc |
| Jun 2, 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... | Class II | Breas Medical, Inc. |
| Jun 1, 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause le... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 1, 2022 | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of... | Class II | Siemens Healthcare Diagnostics Inc |
| May 31, 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not matc... | Class III | Boston Scientific Corporation |
| May 31, 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 20, 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 20, 2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 4, 2022 | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temper... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 26, 2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Due to a shift in the citrated blood reference range for a normal population, the ranges stated i... | Class II | Haemonetics Corporation |
| Apr 26, 2022 | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... | Class II | Beaver Visitec International, Inc. |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... | Class II | Fresenius Kabi USA, LLC |
| Apr 22, 2022 | Ivenix Infusion System (IIS) | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | Class II | Ivenix, Inc. |
| Apr 19, 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or... | Class II | Haemonetics Corporation |
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.