Data / Medical devices / United States / Boston Scientific Corporation
Boston Scientific Corporation: FDA-registered device maker in Spencer, IN, United States, 57 510(k) clearances and 1 PMA approval
Boston Scientific Corporation is registered with the FDA (registration 1828132) in Spencer, IN, United States. It lists 50 device types. The FDA files 57 510(k) clearances and 1 PMA approval under its listings, the newest dated August 26, 2026. 25 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1828132
- Address
- 780 Brookside Drive, Spencer, IN, United States, 47460
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- September 9, 1983
- Registered through
- 2026
- Brand names listed
- AdVance XP Male Sling System, Connecting Tube, Connector Drainage Bag Connector, Connector Ureteral Catheter Connector, EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator, EMBLEM S-ICD Electrode, EMBLEM S-ICD Electrode Delivery System, EMBLEM S-ICD Electrode Insertion System 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 |
|---|---|---|---|---|---|---|
| August 26, 2026 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 4, 2026 | K261915 | Navigator Flex Ureteral Access Sheath Set | FED | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 17, 2026 | K260428 | RIVOS EUS Access Device (M00553900) | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 24, 2025 | K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 3, 2025 | K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| April 15, 2025 | K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | FAD | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 21, 2025 | K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | FED | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 1, 2024 | K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 12, 2023 | K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | FGB | Substantially Equivalent | Boston Scientific Corporation - | accessdata.fda.gov |
| June 29, 2023 | K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | OTN | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 30, 2022 | K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 29, 2022 | K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 20, 2021 | K211847 | AdVance XP Male Sling System | OTM | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 18, 2020 | K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 22, 2019 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | FBN | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 27, 2018 | K182169 | AdVance XP Male Sling | OTM | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 10, 2018 | K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | LJE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 20, 2017 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | PWJ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 27, 2017 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| March 27, 2017 | K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | EOQ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 30, 2017 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| May 3, 2016 | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 13, 2015 | K153049 | LithoVue System | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 22, 2015 | K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | FCG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 29, 2015 | K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | PIF | Unknown | Boston Scientific Corp | accessdata.fda.gov |
| April 17, 2014 | K140495 | LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| January 3, 2014 | K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 10, 2012 | K121754 | BLUE SUI SLING | OTN | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| March 15, 2012 | K113090 | LEVEEN SUPERSLIM NEEDLE ELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 14, 2011 | K112198 | EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 12, 2011 | K110030 | EXPECT ENDOSCOPIC ASPIRATION NEEDLE | ODG | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 23, 2010 | K101786 | ADVANIX DOUBLE PIGTAIL BILIARY STENT | FGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 23, 2010 | K101314 | ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM | FGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| August 27, 2008 | K081275 | BOSTON SCIENTIFIC SURGICAL MESH | PAH | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| March 20, 2008 | K080154 | ACUITY UNIVERSAL CUTTER | DQY | Substantially Equivalent | Cardiac Pacemakers, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071066 | SPYCATCH STONE RETRIEVAL BASKET | LQR | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 30, 2005 | K053128 | SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 14, 2004 | K040787 | MODIFICATION TO SURGICAL MESH POLYMERIC | OTN | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| June 27, 2003 | K031538 | ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT | KNT | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| May 23, 2003 | K030956 | NAVIGATOR URETERAL ACCESS SHEATH SET | FED | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 3, 2002 | K020110 | MODIFICATION TO TRELEX MESH SURGICAL MESH | OTN | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| August 24, 2001 | K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | FFK | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| March 27, 2001 | K010610 | RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 | ODC | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 19, 2000 | K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | FFK | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 16, 1998 | K982508 | FLEXIMA | FGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| June 30, 1997 | K965147 | BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS | FGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| February 10, 1997 | K970054 | TANDEMRX | GCJ | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| September 3, 1993 | K930348 | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | FDX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| February 18, 1992 | K915719 | ANGEION ENDOSCOPIC VALVE SEAL | ODC | Substantially Equivalent | Angeion Corp. | accessdata.fda.gov |
| May 22, 1989 | K891968 | ESP RADIATION REDUCTION EXAMINATION GLOVES | LZC | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| March 10, 1987 | K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER | KOD | Substantially Equivalent | Van-Tec, Inc. | accessdata.fda.gov |
| March 25, 1986 | K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. | KOD | Substantially Equivalent | Van-Tec, Inc. | accessdata.fda.gov |
| April 9, 1985 | K851144 | URETERAL DILATION SET | EZN | Substantially Equivalent | Van-Tec, Inc. | accessdata.fda.gov |
| April 6, 1983 | K830840 | OPEN ENDED URETERAL CATHETER | GBM | Substantially Equivalent | Van-Tec, Inc. | accessdata.fda.gov |
| June 2, 1981 | K811378 | PERCUTANEOUS DRAINING CATHETER | GBW | Substantially Equivalent | Medi-Tech, Inc. | accessdata.fda.gov |
| March 20, 1981 | K810336 | POLYPECTOMY SNARE | KNS | Substantially Equivalent | Medi-Tech, Inc. | accessdata.fda.gov |
| September 7, 1978 | K780872 | CYTOLOGY BRUSH | BTG | Substantially Equivalent | CooperVision, 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 |
|---|---|---|---|---|---|---|
| September 28, 2012 | P110042 | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM | LWS | 208 | October 2, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2015 | 72364 | Class II | Terminated | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button. | accessdata.fda.gov |
| September 17, 2009 | 53582 | Not yet classified | Terminated | Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System mode | The label incorrectly reads "compatible with 330mm ultrasound probes (Ref and )" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref and." | accessdata.fda.gov |
| July 6, 2009 | 52659 | Not yet classified | Terminated | Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation. | The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention. | accessdata.fda.gov |
| May 5, 2009 | 52189 | Not yet classified | Terminated | Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | accessdata.fda.gov |
| January 8, 2009 | 50861 | Not yet classified | Terminated | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic re | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. | accessdata.fda.gov |
| December 30, 2008 | 50749 | Not yet classified | Terminated | Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | accessdata.fda.gov |
| October 17, 2008 | 50087 | Not yet classified | Terminated | Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN, REF M0065001040 and M0065001041. For use to endoscopically or percutaneously retrieve tissue samples of | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | accessdata.fda.gov |
| April 30, 2008 | 48079 | Not yet classified | Terminated | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-226, UPN M001262260. The product is used with a radiofrequency generator for the thermal coagulation necr | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | accessdata.fda.gov |
| April 2, 2008 | 48440 | Not yet classified | Terminated | Boston Scientific Flexima Biliary Stent System, 200 cm long,.035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used for delivery of the stent to the biliary tract for drainage of | Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package. | accessdata.fda.gov |
| October 1, 2007 | 48437 | Not yet classified | Terminated | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation nec | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | accessdata.fda.gov |
| July 19, 2007 | 38471 | Not yet classified | Terminated | Boston Scientific ACCUSTICK II Introducer System with.038 inch Stainless Steel J Tip and.018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick | Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use. | accessdata.fda.gov |
| September 21, 2006 | 36439 | Not yet classified | Terminated | Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350. | Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed. | accessdata.fda.gov |
| August 10, 2006 | 36136 | Not yet classified | Terminated | Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201. | Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. | accessdata.fda.gov |
| June 30, 2006 | 35748 | Not yet classified | Terminated | Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251. | Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them. | accessdata.fda.gov |
| June 2, 2006 | 35724 | Not yet classified | Terminated | Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No., UPN Product No. (M0068201000). | The packages are labeled sterile, but the product was not sterilized. | accessdata.fda.gov |
| May 19, 2006 | 35535 | Not yet classified | Terminated | Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511. | Lack of assurance of sterility, as the sterile barrier may fail. | accessdata.fda.gov |
| May 10, 2006 | 35494 | Not yet classified | Terminated | Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent. | Instructions on how to inject are not included in the package. | accessdata.fda.gov |
| December 20, 2005 | 34300 | Not yet classified | Terminated | Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no.. | The basket wire assembly may detach from the drive wire while in the patient. | accessdata.fda.gov |
| December 8, 2005 | 34241 | Not yet classified | Terminated | Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401. | The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing. | accessdata.fda.gov |
| July 29, 2005 | 33089 | Not yet classified | Terminated | Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216. | Firm has received complaints of extended ablation times, lack of roll-off and patient burns. | accessdata.fda.gov |
| July 15, 2005 | 32764 | Not yet classified | Terminated | Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240. | The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors. | accessdata.fda.gov |
| June 2, 2005 | 32383 | Not yet classified | Terminated | Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 18/2.4, pull; Catalog number 6314. | Two blades may be heat staked onto the stiletto instead of the expected one blade. | accessdata.fda.gov |
| June 25, 2004 | 29486 | Not yet classified | Terminated | Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885. | Mislabeled as to size; 10FR are labeled as 8FR. | accessdata.fda.gov |
| June 18, 2004 | 29418 | Not yet classified | Terminated | Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101. | Mislabeled as to length; 10 cm length labeled as 5 cm. | accessdata.fda.gov |
| June 16, 2004 | 29476 | Not yet classified | Terminated | Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154. | Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa. | accessdata.fda.gov |
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Updated October 2, 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.