Browse Device Recalls

3,494 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,494 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 3,494 FDA device recalls in MA.

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DateProductReasonClassFirm
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 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 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 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.

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.