Data / Medical devices / United States / Vascular Solutions LLC
Vascular Solutions LLC: FDA-registered device maker in Maple Grove, MN, United States, 54 510(k) clearances and 2 PMA approvals
Vascular Solutions LLC is registered with the FDA (registration 2134812) in Maple Grove, MN, United States. It lists 28 device types. The FDA files 54 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 31, 2024. 22 recall events name it as the recalling firm (7 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2134812
- FEI number
- 3002827704
- Address
- 6464 Sycamore Court North, Maple Grove, MN, United States, 55369
- Owner or operator
- Vascular Solutions LLC (9029941)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 30, 2002
- Registered through
- 2026
- Brand names listed
- Accumed II Wrist Positioning Splint, Accumed LP Wrist Positioning Splint, AngioAssist docking station, D-Stat Dry topical hemostat, D-Stat Flowable Hemostat, Drainer Centesis Catheter, FlexBlock® Continuous Peripheral Nerve Block Kit, FlexTip Plus Combined Spinal Epidural Catheterization Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2024 | K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| May 5, 2023 | K230637 | Wattson temporary pacing guidewire (2250) | DQX | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| August 18, 2022 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| June 17, 2022 | K221470 | Langston dual lumen catheter | DQO | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| April 30, 2021 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| June 29, 2020 | K193119 | Twin-Pass Dual Access Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| June 26, 2020 | K200720 | D-Stat Radial Topical Hemostat | QSX | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| January 15, 2020 | K192454 | Wattson Temporary Pacing Guidewire | DQX | Substantially Equivalent | Vascular Solutions | accessdata.fda.gov |
| August 9, 2019 | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| March 13, 2019 | K182570 | Venture 0.014 Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| July 20, 2018 | K181647 | Bandit guidewire | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| May 9, 2018 | K180913 | VSI Micro-Introducer Kit | DYB | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 16, 2018 | K180128 | Warrior 14 guidewire | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 19, 2018 | K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | KRD | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 15, 2017 | K173532 | Raider Guidewire | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 20, 2017 | K172090 | GuideLiner V3 Catheter | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| March 8, 2017 | K163307 | Expro Elite Snare, Sympro Elite Snare | MMX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 3, 2017 | K161901 | TrapLiner catheter | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 1, 2017 | K162467 | Twin-Pass Torque | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 6, 2017 | K163444 | Spectre guidewire | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| June 23, 2016 | K153682 | Chocolate XD PTCA Balloon Catheter | LOX | Substantially Equivalent | Trireme Medical, LLC | accessdata.fda.gov |
| November 18, 2015 | K151234 | R350 guidewire | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 17, 2014 | K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | KNW | Substantially Equivalent | Vidacare, LLC | accessdata.fda.gov |
| November 20, 2014 | K143038 | Gel-Block 10X embolization pledgets | KRD | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| September 7, 2012 | K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | DTL | Substantially Equivalent | Vascular Solutions Zerusa , Ltd. | accessdata.fda.gov |
| June 26, 2012 | K121681 | GLIDER PTCA BALLOON CATHETER | LOX | Substantially Equivalent | Trireme Medical, Inc. | accessdata.fda.gov |
| March 8, 2012 | K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE | KNW | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| October 27, 2011 | K112631 | VSI GUIDEWIRE | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| September 27, 2011 | K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | DXC | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. | accessdata.fda.gov |
| April 8, 2011 | K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 22, 2010 | K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| April 30, 2010 | K100093 | VSI TORQUE DEVICE | DQX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 7, 2010 | K093502 | VARI-LASE ENDOVENOUS LASER CONSOLE | GEX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 23, 2009 | K093613 | VASCUVIEW TAP ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Escalon Medical Corp. | accessdata.fda.gov |
| September 11, 2009 | K092612 | D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| June 19, 2009 | K091551 | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER | GEX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| June 18, 2009 | K090977 | PIGGYBACK WIRE CONVERTER | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| March 30, 2009 | K083784 | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 28, 2009 | K081846 | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 | DQO | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 15, 2009 | K082337 | MINNIE SUPPORT CATHETER | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 7, 2007 | K073264 | D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 22, 2007 | K072045 | ONCONTROL BONE MARROW BIOPSY SYSTEM | KNW | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| October 5, 2007 | K072117 | THROMBIX PATCH THROMBIN HEMOSTASIS PATCH | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 4, 2007 | K070502 | RADIUS SNARE | DQY | Substantially Equivalent | Radius Medical Technologies, Inc. | accessdata.fda.gov |
| June 13, 2007 | K070403 | PRONTO .035 EXTRACTION CATHETER | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 13, 2007 | K063860 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 6, 2006 | K061219 | D-STAT DRY HEMOSTATIC BANDAGE | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| November 23, 2005 | K053054 | THROMBIX 3X3 HEMOSTATIC PAD | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| July 29, 2005 | K051287 | VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | GEX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| May 27, 2005 | K050146 | VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY | DXC | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 9, 2005 | K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| December 18, 2003 | K033709 | VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| November 20, 2003 | K033237 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE | GEX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| January 18, 2002 | K012293 | VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT | QSX | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 1, 2019 | P180025 | MANTA Vascular Closure Device | MGB | 14 | April 23, 2026 | accessdata.fda.gov |
| June 22, 2000 | P990037 | VASCULAR SOLUTIONS DUETT SEALING DEVICE | MGB | 31 | November 4, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2020 | 86433 | Class I | Terminated | Langston Dual Lumen Catheter | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | accessdata.fda.gov |
| March 16, 2020 | 85350 | Class I | Terminated | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | accessdata.fda.gov |
| May 4, 2018 | 80135 | Class II | Terminated | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage p | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins. | accessdata.fda.gov |
| April 25, 2017 | 77202 | Class I | Terminated | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and su | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use. | accessdata.fda.gov |
| April 12, 2017 | 77095 | Class II | Terminated | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) ballo | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection. | accessdata.fda.gov |
| January 12, 2017 | 76363 | Class II | Terminated | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. | accessdata.fda.gov |
| September 16, 2016 | 75243 | Class I | Terminated | Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripher | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. | accessdata.fda.gov |
| March 4, 2016 | 73553 | Class I | Terminated | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as | Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. | accessdata.fda.gov |
| May 27, 2014 | 68489 | Class I | Terminated | Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiogra | The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury. | accessdata.fda.gov |
| February 27, 2013 | 64511 | Class I | Terminated | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 82 | Risk that air may be introduced into the device which may lead to an air embolism. | accessdata.fda.gov |
| January 29, 2013 | 64215 | Class II | Terminated | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be us | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. | accessdata.fda.gov |
| August 30, 2012 | 63098 | Class II | Terminated | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a se | Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination. | accessdata.fda.gov |
| January 17, 2012 | 61825 | Not yet classified | Terminated | Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to a | Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention. | accessdata.fda.gov |
| July 11, 2011 | 59368 | Not yet classified | Terminated | Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. The Pronto | Vascular Solutions, Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patient which may require medical interven | accessdata.fda.gov |
| June 9, 2011 | 59003 | Not yet classified | Terminated | Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for deliv | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possib | accessdata.fda.gov |
| January 10, 2011 | 57847 | Not yet classified | Terminated | Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369 The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicositie | Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur du | accessdata.fda.gov |
| September 2, 2010 | 56709 | Not yet classified | Terminated | Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Usage: Indicated fo | Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk o | accessdata.fda.gov |
| November 20, 2009 | 53938 | Not yet classified | Terminated | Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered throu | It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009. | accessdata.fda.gov |
| July 2, 2009 | 52633 | Not yet classified | Terminated | Twin-Pass Dual Access Catheter, REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended | Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging | accessdata.fda.gov |
| September 9, 2005 | 33456 | Not yet classified | Terminated | D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists o | A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question. | accessdata.fda.gov |
| May 12, 2004 | 29391 | Not yet classified | Terminated | The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. | The marker band in guidewire lumen could move from the manufactured location during clinical use. | accessdata.fda.gov |
| October 9, 2003 | 27557 | Not yet classified | Terminated | Vari-Lase Endovenous Laser Procedural Kit, Model 7000 | An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement. | accessdata.fda.gov |
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Updated April 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.