Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Dec 19, 2019 LEGION PS High Flex XLPE size 5-6 9mm Articular Insert LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part Class II Smith & Nephew, Inc.
Dec 11, 2019 Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Circumsion Trays as follows: Kit Code Product ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- LC145 STERILE NICU LINE CHANGE KIT Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 3, 2019 Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ... Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos... Class II Johnson & Johnson Surgical Vision Inc
Dec 2, 2019 HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob... Class II Thoratec Corp.
Nov 27, 2019 QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:... If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e... Class II Edwards Lifesciences, LLC
Nov 21, 2019 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... Pin To Rod Coupling could not clamp the pin and rod as intended Class II Stryker GmbH
Nov 15, 2019 O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ... Class II Medtronic Navigation, Inc.-Littleton
Nov 15, 2019 Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L There is the potential presence of particular matter in the header caps of ten lots the Revaclear... Class II Baxter Healthcare Corporation
Oct 10, 2019 Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... Class II Nextremity Solutions
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 4, 2019 REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-w... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, ... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hang... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, F... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Mani... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing,... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pr... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopco... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 3, 2019 Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos ... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Oct 3, 2019 Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embr... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Sep 3, 2019 Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Aug 30, 2019 Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accesso... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used a... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 26, 2019 Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-... The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... Class II LivaNova Deutschland GmbH
Aug 26, 2019 Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15,... The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... Class II LivaNova Deutschland GmbH
Aug 19, 2019 RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (1... It has been determined that some units of catheters were not tightly connected to the thumb port.... Class II RESPIRATORY THERAPEUTICS GROUP LLC
Aug 7, 2019 CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... possibility of the sterility batch being insufficiently sterilized Class II Aesculap Implant Systems LLC
Aug 7, 2019 CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... possibility of the sterility batch being insufficiently sterilized Class II Aesculap Implant Systems LLC
Jul 31, 2019 HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... software error in the central control unit of the floor stand. Class II Haag-Streit USA Inc
Jul 31, 2019 HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... software error in the central control unit of the floor stand. Class II Haag-Streit USA 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.