Browse Device Recalls
3,378 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,378 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 3,378 FDA device recalls in MA.
| 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 | 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 | 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 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 8, 2024 | GM60A. Digital Diagnostic Mobile X-Ray System. | Potential for the anti-fall system of the device arm to fail. | Class II | NeuroLogica Corporation |
| Jun 28, 2024 | IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x ent... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 27, 2024 | Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Sut... | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... | Class II | Boston Scientific Corporation |
| Jun 27, 2024 | Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261,... | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... | Class II | Boston Scientific Corporation |
| Jun 18, 2024 | FoundationOne Companion Diagnostic (F1CDx) | Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the d... | Class II | Foundation Medicine, Inc. |
| Jun 12, 2024 | Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M... | Foreign material may be present on the enclosed section of the cutting wire which may lead to ina... | Class II | Boston Scientific Corporation |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdo... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 4, 2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply... | Class II | Zyno Medical LLC |
| Jun 3, 2024 | RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Mode... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare p... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part,... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare p... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2024 | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... | Nine (9) Impella CP pumps failed inspection and were inadvertently released. | Class I | Abiomed, Inc. |
| May 22, 2024 | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the f... | Potential for inaccurate fetal heart rate measurements when monitoring multiples. | Class II | Philips North America Llc |
| May 17, 2024 | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... | Class II | Siemens Healthcare Diagnostics Inc |
| May 16, 2024 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point ran... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 14, 2024 | NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Cata... | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two ... | Class II | NxStage Medical Inc |
| May 13, 2024 | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power... | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standa... | Class II | Draeger Medical Systems, Inc. |
| May 10, 2024 | Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a compone... | The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... | Class II | Beaver Visitec International, Inc. |
| May 10, 2024 | Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227 | The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... | Class II | Beaver Visitec International, Inc. |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T TX for PET Model Number (REF): 781479 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T S Model Number (REF): 781347 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
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.